Data / Medical devices / Vietnam / Viet Glove Corporation
Viet Glove Corporation: FDA-registered device maker in Ben Cat Ward Ho Chi Minh, Vietnam, 4 510(k) clearances
Viet Glove Corporation is registered with the FDA (registration 3012446547) in Ben Cat Ward Ho Chi Minh, Vietnam. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 24, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012446547
- Address
- Land Lot No. 03, Map No. 37, Cau Sat Hamlet, Ben Cat Ward Ho Chi Minh, Vietnam, 75950
- Owner or operator
- Viet Glove Corporation (10050245)
- Roles
- Manufacturer
- First device listed
- October 28, 2016
- Registered through
- 2026
- Brand names listed
- Powder Free Black Nitrile Examination Glove, Powder Free Blue Nitrile Examination Glove, Powder Free Latex Examination Glove with Protein Labeling Claim Of 50ug/dm2 Or Less, Powder Free Latex Examination Glove, Polymer Coated
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 24, 2021 | K201428 | Powder Free Black Nitrile Examination Glove | LZA | Substantially Equivalent | Vietglove Corporation | accessdata.fda.gov |
| June 23, 2017 | K170094 | POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED | LYY | Substantially Equivalent | Vietglove Corporation | accessdata.fda.gov |
| November 21, 2016 | K162175 | Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less | LYY | Substantially Equivalent | Vietglove Corporation | accessdata.fda.gov |
| April 1, 2016 | K153562 | Powder Free Blue Nitrile Examination Glove | LZA | Substantially Equivalent | Vietglove Corporation | accessdata.fda.gov |
Compare with other makers
Updated June 24, 2021. 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.