Data / Medical devices / United States / Bosma Industries For The Blind, Inc.
Bosma Industries For The Blind, Inc.: FDA-registered device maker in Indianapolis, IN, United States, 38 510(k) clearances
Bosma Industries For The Blind, Inc. is registered with the FDA (registration 1833700) in Indianapolis, IN, United States. It lists 11 device types. The FDA files 38 510(k) clearances under its listings, the newest dated February 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1833700
- FEI number
- 1000115586
- Address
- 6270 Corporate Drive, Indianapolis, IN, United States, 46278
- Owner or operator
- BOSMA INDUSTRIES FOR THE BLIND, INC. (9024211)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 10, 2019
- Registered through
- 2026
- Brand names listed
- Catheter, Urological (Straight-Tip), #10-277708-#10-277718, Flex, Good Works Performance Pro Exam Gloves, Vinyl patient examination glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Clean-Up Kit | PWU | 1 | Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dental Hygiene Kit | NXZ | 1 | Manufacturer | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2026 | K251864 | Rubber Utility Catheter | KOD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 8, 2022 | K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | LZA | Substantially Equivalent | American Nitrile Operations, LLC | accessdata.fda.gov |
| June 19, 2020 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| April 2, 2020 | K193095 | Ambu aScope 4 Cysto | FAJ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| February 28, 2020 | K192820 | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 22, 2019 | K191080 | Ambu aScope 4 RhinoLaryngo Slim | EOB | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| March 28, 2018 | K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor | EOQ | Substantially Equivalent | Ambu A/S | accessdata.fda.gov |
| November 27, 2015 | K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| November 2, 2015 | K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| August 31, 2015 | K150146 | Biogel PI Micro Indicator Underglove | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 4, 2014 | K141719 | BIOGEL PL MICRO SURGICAL GLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| April 27, 2012 | K113707 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING | KGO | Substantially Equivalent | Cardinal Health-Medical Products and Services | accessdata.fda.gov |
| September 21, 2011 | K111868 | STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING | KGO | Substantially Equivalent | Cardinal Health-Medical Products and Services | accessdata.fda.gov |
| September 20, 2011 | K112257 | BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 2, 2011 | K111139 | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U | KGO | Substantially Equivalent | Ansell Healthcare Products, Inc. | accessdata.fda.gov |
| July 7, 2011 | K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| June 8, 2011 | K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 6, 2011 | K111015 | STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| October 30, 2009 | K093300 | ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| September 15, 2009 | K092304 | ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| August 26, 2008 | K081180 | SKINSENSE POLYISOPRENE UNDERGLOVE | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| December 13, 2007 | K071746 | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| September 11, 2007 | K071700 | BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| September 10, 2007 | K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| February 22, 2007 | K070076 | POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| April 10, 2006 | K053441 | BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 10, 2006 | K053102 | BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| August 12, 2005 | K050899 | BIOGEL LATEX STERILE POWDER-FREE GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 16, 2005 | K050184 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| March 16, 2004 | K040503 | ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| October 15, 2003 | K031301 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING | KGO | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| August 14, 2001 | K011721 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| March 30, 2001 | K010097 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| August 14, 2000 | K000421 | BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE | KGO | Substantially Equivalent | Ssl Americas, Inc. (Regent Medical) | accessdata.fda.gov |
| February 16, 2000 | K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| October 29, 1999 | K992953 | SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| February 26, 1999 | K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| December 14, 1998 | K983489 | ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Dental Hygiene Kit
- All makers of Vinyl Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Nasopharyngoscope (Flexible Or Rigid)
Updated February 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.