Identity
- Trade Name
- Annuy Powder-free Latex Patient Examination Glove FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- A non-sterile device made of natural latex intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes. FDA UDI
- Model / Reference
- S FDA UDI
- Description
- A non-sterile device made of natural latex intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16928965100010 FDA UDI
- 510(k) Number
- K150612 FDA UDI
- FDA Product Code
- LYY FDA UDI
- GMDN Term
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Annuy Powder-free Latex Patient Examination Glove by Anhui Annuy Latex Products Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial.
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Cleared under the same submission
K150612 also covers:
- Annuy Powder-free Latex Patient Examination Glove — Anhui Annuy Latex Products Co., Ltd.
- Annuy Powder-free Latex Patient Examination Glove — Anhui Annuy Latex Products Co., Ltd.
- Annuy Powder-free Nitrile Patient Examination Glove — Anhui Annuy Latex Products Co., Ltd.
- Annuy Powder-free Nitrile Patient Examination Glove — Anhui Annuy Latex Products Co., Ltd.
- Annuy Powder-free Nitrile Patient Examination Glove — Anhui Annuy Latex Products Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Anhui Annuy Latex Products Co., Ltd.
Sources (1)
- FDA UDI 27807b83-0435-41a3-b359-12e18dc77154 34 fields · synced Jun 6, 2026