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Disposable Sterilized Latex Surgical Gloves
FDA UDIClass I (US FDA UDI)
by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Identity
- Trade Name
- Disposable Sterilized Latex Surgical Gloves FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package. Immediate package quantity: 1 pair Middle box package quantity: 50 pairs Outer carton package quantity: 400 pairs FDA UDI
- Model / Reference
- 7.5 FDA UDI
- Description
- Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package. Immediate package quantity: 1 pair Middle box package quantity: 50 pairs Outer carton package quantity: 400 pairs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972267280126 FDA UDI
- 510(k) Number
- K211953 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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 surgical glove, non-powdered, non-antimicrobial
Disposable Sterilized Latex Surgical Gloves by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Hevea-latex surgical glove, non-powdered, non-antimicrobial.
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Prestige® Micro — INNOVATIVE HEALTHCARE CORPORATION · Class I
- Biogel — Bosma Enterprises · Class I
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- HALYARD — Ansell Healthcare Product · Class I
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd. · Class I
- HALYARD — Ansell Healthcare Product · Class I
Cleared under the same submission
K211953 also covers:
- Disposable Sterilized Latex Surgical Gloves — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Disposable Sterilized Latex Surgical Gloves — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Disposable Sterilized Latex Surgical Gloves — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Disposable Sterilized Latex Surgical Gloves — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Disposable Sterilized Latex Surgical Gloves — Jiangxi Kemei Medical Apparatus & Instruments Group 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
Sources (1)
- FDA UDI 5e1fccd1-76b9-408d-be95-a863a57f8835 34 fields · synced May 29, 2026