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Sign in to claim this brandAustin Pang Gloves Mfg (u.s.a.) Corp.
US
Last updated May 27, 2026
What Austin Pang Gloves Mfg (u.s.a.) Corp. makes
The company manufactures single-use examination and treatment gloves made from nitrile, natural hevea latex, and polychloroprene. These gloves are non-powdered and, where applicable, non-antimicrobial, designed for medical and clinical use. The portfolio includes both standard and high-risk protection variants for healthcare procedures.
All listed devices fall under FDA Class I regulation and are registered in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for medical gloves.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Austin Pang Gloves Mfg (U.S.A.) Corp. manufacture?
Austin Pang Gloves Mfg (U.S.A.) Corp. specializes in single-use examination and treatment gloves for medical and clinical settings. Their portfolio includes nitrile, natural hevea latex, and polychloroprene gloves, all of which are non-powdered. Some latex gloves are also non-antimicrobial. These gloves are designed for general medical procedures as well as higher-risk applications, ensuring protection for both patients and healthcare providers.
Where is Austin Pang Gloves Mfg (U.S.A.) Corp. based, and how does this affect their devices?
The company is based in the United States, which means their medical gloves are manufactured and regulated under U.S. standards. Since they produce Class I devices, they must comply with FDA requirements for single-use gloves, including quality control, labeling, and registration in the FDA’s Unique Device Identifier (UDI) database. This ensures their products meet U.S. regulatory expectations for safety and performance.
Which regulatory registries list Austin Pang Gloves Mfg (U.S.A.) Corp.’s devices?
Austin Pang Gloves Mfg (U.S.A.) Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices, ensuring transparency and traceability in the healthcare supply chain. Since these gloves fall under FDA Class I regulation, they are subject to mandatory UDI labeling and registration.
How are Austin Pang Gloves Mfg (U.S.A.) Corp.’s gloves classified by the FDA?
All of Austin Pang Gloves Mfg (U.S.A.) Corp.’s gloves are classified as FDA Class I devices. This classification applies to low-risk medical devices like single-use examination and treatment gloves, which are generally considered safe and effective when used as intended. Class I devices typically require less regulatory oversight than higher-risk categories but still must meet FDA labeling, manufacturing, and registration requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- jwisafety.com
- —
- —
- [email protected]
- Phone
- 5627770088
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 072794423
Catalogue (78)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Neoflex | 8900XS | FDA UDI | Class I | Active |
| Elite Latex | 8411S | FDA UDI | Class I | Active |
| Blk | JW9770S | FDA UDI | Class I | Active |
| Pivotal | 9770FTL | FDA UDI | Class I | Active |
| HyperFlex | 8713M | FDA UDI | Class I | Active |
| Elite | 8703AS | FDA UDI | Class I | Active |
| Pivotal | 9770FTS | FDA UDI | Class I | Active |
| Neoflex | 89012XL | FDA UDI | Class I | Active |
| Elite High Risk | 84015L | FDA UDI | Class I | Active |
| Elite | 8723XS | FDA UDI | Class I | Active |
| Neoflex | 8900XL | FDA UDI | Class I | Active |
| Elite | 8723L | FDA UDI | Class I | Active |
| Elite Protective | 8702AM | FDA UDI | Class I | Active |
| BLK Pro | 9774L | FDA UDI | Class I | Active |
| Elite Protective | 8702AS | FDA UDI | Class I | Active |
| Vigor | 8778L | FDA UDI | Class I | Active |
| HyperFlex | 8713XXL | FDA UDI | Class I | Active |
| Elite High Risk | 84015S | FDA UDI | Class I | Active |
| Elite Protective Extra | 8720XXL | FDA UDI | Class I | Active |
| HyperFlex | 8713L | FDA UDI | Class I | Active |
| Neoflex | 8900S | FDA UDI | Class I | Active |
| Elite Protective | 8702AL | FDA UDI | Class I | Active |
| Elite Protective Extra | 8720M | FDA UDI | Class I | Active |
| Neoflex | 8900M | FDA UDI | Class I | Active |
| Neoflex | 89012L | FDA UDI | Class I | Active |
| Neoflex | 89012S | FDA UDI | Class I | Active |
| Vigor | 8778XL | FDA UDI | Class I | Active |
| Elite Protective | 8702AXL | FDA UDI | Class I | Active |
| Elite Protective Extra | 8720XL | FDA UDI | Class I | Active |
| HyperFlex | 8713XL | FDA UDI | Class I | Active |
| BLK Pro | 9774S | FDA UDI | Class I | Active |
| Elite Protective Extra | 8720L | FDA UDI | Class I | Active |
| Safety First | 8773AL | FDA UDI | Class I | Active |
| Elite High Risk | 84015M | FDA UDI | Class I | Active |
| Safety First | 8773AXXL | FDA UDI | Class I | Active |
| Pivotal | 9770FTXL | FDA UDI | Class I | Active |
| Elite Latex | 8411L | FDA UDI | Class I | Active |
| Elite | 8723XL | FDA UDI | Class I | Active |
| Blk+ | 9771L | FDA UDI | Class I | Active |
| BLK Pro | 9774M | FDA UDI | Class I | Active |
| Blk | JW9770XL | FDA UDI | Class I | Active |
| Safety First | 8773AM | FDA UDI | Class I | Active |
| Elite | 8703AM | FDA UDI | Class I | Active |
| Blk | JW9770M | FDA UDI | Class I | Active |
| Vigor | 8778XXL | FDA UDI | Class I | Active |
| Elite High Risk | 84015XL | FDA UDI | Class I | Active |
| Pivotal | 9770FTM | FDA UDI | Class I | Active |
| Elite High Risk | 84015XXL | FDA UDI | Class I | Active |
| Elite | 8723S | FDA UDI | Class I | Active |
| HyperFlex | 8713S | FDA UDI | Class I | Active |
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