Data / Medical devices / Vietnam / S&S Glove Corporation- Branch 1
S&S Glove Corporation- Branch 1: FDA-registered device maker in Ho Chi Minh City Ba Ria-Vung Tau, Vietnam, 2 510(k) clearances
S&S Glove Corporation- Branch 1 is registered with the FDA (registration 3028652705) in Ho Chi Minh City Ba Ria-Vung Tau, Vietnam. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3028652705
- Address
- NB B2, Lot 4, Road D6, Dat Do I Industrial Park Dat Do Commune, Ho Chi Minh City Ba Ria-Vung Tau, Vietnam, 790000
- Owner or operator
- S&S Glove Corporation - Branch 1 (10091647)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 21, 2024
- Registered through
- 2027
- Brand names listed
- Polymer Patient examination Glove, Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl, Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl, polymer patient examination glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 11, 2023 | K231439 | Powder Free White, Black, and Purple Nitrile Examination Glove | LZA | Substantially Equivalent | S&S Glove Corporation | accessdata.fda.gov |
| February 6, 2023 | K223444 | Powder Free Blue Nitrile Examination Glove | LZA | Substantially Equivalent | S&S Glove Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Polymer Patient Examination Glove
Updated August 11, 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.