Identity
- Trade Name
- MEDADV FDA UDI
- Generic Name
- Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Polyisoprene Surgical Gloves - Powder Free - Latex Free - Water-Soluble Protein Free - Size 7.0 FDA UDI
- Model / Reference
- M716 FDA UDI
- Description
- Polyisoprene Surgical Gloves - Powder Free - Latex Free - Water-Soluble Protein Free - Size 7.0 FDA UDI
Identifiers
- Catalog Number
- M716 FDA UDI
- Primary DI / UDI-DI
- 10819667020101 FDA UDI
- 510(k) Number
- K123126 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Polyisoprene 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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: Polyisoprene surgical glove, non-powdered, non-antimicrobial
Medadv by Medas, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyisoprene surgical glove, non-powdered, non-antimicrobial.
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- Biogel® PI Micro Indicator® Underglove — Mölnlycke Health Care AB · Class I
- Sempermed Syntegra UV Polyisoprene Surgical Glove — SEMPERMED USA, INC.
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- GAMMEX — Ansell Healthcare Product · Class I
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Cleared under the same submission
K123126 also covers:
- MEDADV — MEDAS, INC.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare Co., Ltd.
- MocareHealth — Shanghai Motex Healthcare 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medas, Inc.
Sources (1)
- FDA UDI 87458cd2-7c72-4e0c-b38b-94e47f5b40c2 37 fields · synced May 30, 2026