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MocareHealth

FDA UDI

Class I (US FDA UDI)

by Shanghai Motex Healthcare Co., Ltd.

Identity

Trade Name
MocareHealth FDA UDI
Generic Name
Nitrile examination/treatment glove, powdered FDA UDI
Device Name
Nitrile Medical Examination Gloves, powder-free, latex-free, blue color, ambidextrous, beaded cuff, textured surface in the grip area, non-sterile. FDA UDI
Model / Reference
723580 FDA UDI
Description
Nitrile Medical Examination Gloves, powder-free, latex-free, blue color, ambidextrous, beaded cuff, textured surface in the grip area, non-sterile. FDA UDI

Identifiers

Primary DI / UDI-DI
06930518036854 FDA UDI
510(k) Number
K030207 FDA UDI
FDA Product Code
LZA FDA UDI
GMDN Term
Nitrile examination/treatment glove, powdered 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

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nitrile examination/treatment glove, powdered

MocareHealth by Shanghai Motex Healthcare Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrile examination/treatment glove, powdered.

Cleared under the same submission

K030207 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai Motex Healthcare Co., Ltd.

Sources (1)

  • FDA UDI 861790e3-2b2e-4045-8ada-6242c9c8607c 34 fields · synced Jun 6, 2026