Data / Medical devices / United States / GCB Medical LLC
GCB Medical LLC: FDA-registered device maker in Duxbury, MA, United States, 8 510(k) clearances
GCB Medical LLC is registered with the FDA (registration 3030419987) in Duxbury, MA, United States. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030419987
- Address
- 25 Depot St, Duxbury, MA, United States, 02332
- Owner or operator
- GCB Medical LLC (10090007)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 1, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Complaint file establishment | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | 1 | Complaint file establishment | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Complaint file establishment | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| September 29, 2023 | K220458 | UltraFlo-R Push Button Blood Collection Set | JKA | Substantially Equivalent | Innovative Medical Technologies, Inc. | accessdata.fda.gov |
| February 10, 2023 | K222129 | Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | LZA | Substantially Equivalent | Top Glove Medical (Thailand) Co., Ltd. | accessdata.fda.gov |
| November 11, 2022 | K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| May 11, 2022 | K213177 | Plus Medical Cover Gown | FYA | Substantially Equivalent | Foshan Nanhai Plus Medical Co, Ltd. | accessdata.fda.gov |
| September 9, 2020 | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter | JKA | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
| July 17, 2013 | K123787 | GREENCROSS SURGICAL MASK | FXX | Substantially Equivalent | Jingzhou Haixin Green Cross Medical Products Co.,L | accessdata.fda.gov |
| May 3, 2004 | K040856 | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | MPO | Substantially Equivalent | Rapid Aid , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Infant Heel Warmer (Chemical Heat Pack)
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Needle, Hypodermic, Single Lumen
Updated September 29, 2023. 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.