Identity
- Trade Name
- MocareHealth FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Sterile Polyisoprene Powder-Free Surgical Gloves - Natural FDA UDI
- Model / Reference
- 7621S/5.5 FDA UDI
- Description
- Sterile Polyisoprene Powder-Free Surgical Gloves - Natural FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16971384153853 FDA UDI
- 510(k) Number
- K063757 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Hevea-latex surgical glove, non-powdered, non-antimicrobial
MocareHealth by Motex Healthcare(Anhui)Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hevea-latex surgical glove, non-powdered, non-antimicrobial.
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- HALYARD — Ansell Healthcare Product · Class I
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Cleared under the same submission
K063757 also covers:
- SUPERFIT — APPLIED DENTAL, INC.
- SUPERFIT — APPLIED DENTAL, INC.
- MEDADV — MEDAS, INC.
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd.
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd.
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd.
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd.
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd.
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd.
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd.
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd.
- MocareHealth — Motex Healthcare(Anhui)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
- Motex Healthcare(Anhui)Co., Ltd.
Sources (1)
- FDA UDI 7a98507f-1306-4d9c-b9ce-d66652360afa 34 fields · synced May 30, 2026