Data / Medical devices / United States / Unisafe Inc.
Unisafe Inc.: FDA-registered device maker in Bohemia, NY, United States, 3 510(k) clearances
Unisafe Inc. is registered with the FDA (registration 3005322833) in Bohemia, NY, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 10, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005322833
- Address
- 80 Orville Dr Ste 112, Bohemia, NY, United States, 11716
- Owner or operator
- UNISAFE INC. (9102881)
- Roles
- Specification developer
- First device listed
- April 4, 2025
- Registered through
- 2027
- Brand names listed
- ON GUARD, Topgrip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 10, 2018 | K172867 | Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange | LZA | Substantially Equivalent | Gmp Medicare Sdn Bhd (F25) | accessdata.fda.gov |
| May 9, 2017 | K170393 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) | LZA | Substantially Equivalent | Zibo Chengxun Automatic Device Co., Ltd. | accessdata.fda.gov |
| December 13, 2013 | K132484 | DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated May 10, 2018. 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.