Data / Medical devices / United States / Haywood Vocational Opportunities Inc.
Haywood Vocational Opportunities Inc.: FDA-registered device maker in Waynesville, NC, United States, 26 510(k) clearances
Haywood Vocational Opportunities Inc. is registered with the FDA (registration 1043549) in Waynesville, NC, United States. It lists 18 device types. The FDA files 26 510(k) clearances under its listings, the newest dated February 11, 2015. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1043549
- Address
- 150 Westwood Circle, Waynesville, NC, United States, 28786
- Owner or operator
- Haywood Vocational Opportunities Inc. (1043549)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- August 10, 2005
- Registered through
- 2027
- Brand names listed
- 581725, Basin with attached drape for Intratemp fluid warming unit, EC02218 Front Panel Drape, HVO, Haywood County Emergency Medical Services, ITB100 Intratemp Basin Drape, OPH 503 NS, criterion cl glove pf latex
Devices it lists
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 11, 2015 | K142685 | NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| July 3, 2014 | K133689 | POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| December 27, 2012 | K121549 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| August 23, 2011 | K111589 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG | LZA | Substantially Equivalent | Derma Care Plus Products, LLC | accessdata.fda.gov |
| August 19, 2011 | K103734 | POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| April 15, 2011 | K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| March 23, 2011 | K103650 | NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM | LYY | Substantially Equivalent | Oon Corp. Resources | accessdata.fda.gov |
| November 29, 2010 | K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| February 19, 2010 | K093759 | MULTIPLE NAME MODEL MULTIPLE | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd (Plant 1) | accessdata.fda.gov |
| February 12, 2010 | K093696 | SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| November 4, 2009 | K092072 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| September 16, 2009 | K092200 | POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| August 11, 2008 | K081315 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| July 24, 2007 | K071119 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) | LZA | Substantially Equivalent | Gx Corporation Sdn Bhd | accessdata.fda.gov |
| June 7, 2007 | K070760 | POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE | LYY | Substantially Equivalent | Derma Care Plus Products, LLC | accessdata.fda.gov |
| April 27, 2005 | K050508 | HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES | KKX | Substantially Equivalent | Haywood Vocational Opportunities | accessdata.fda.gov |
| December 20, 2002 | K024121 | NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| October 3, 2002 | K022904 | DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| June 6, 2002 | K021220 | NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| September 8, 2000 | K002579 | DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS) | LYY | Substantially Equivalent | Wrp Specialty Products Sdn. Bhd. | accessdata.fda.gov |
| May 23, 2000 | K001190 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE | LYY | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| April 23, 1999 | K991044 | DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) | LYY | Substantially Equivalent | Wrp Specialty Products Sdn. Bhd. | accessdata.fda.gov |
| December 7, 1998 | K981917 | POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Oon Corp. Resources | accessdata.fda.gov |
| November 5, 1998 | K981064 | POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
| May 6, 1997 | K970794 | LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| June 27, 1996 | K953590 | COMFIT | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Dressing, Wound, Drug
- All makers of Latex Patient Examination Glove
- All makers of Sheet, Burn
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of Non-Surgical Gown
Updated February 11, 2015. 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.