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Orcare Surgical Latex Pf

FDA UDI

Class I (US FDA UDI)

by Careglove Global Sdn. Bhd.

Identity

Trade Name
ORCARE SURGICAL LATEX PF FDA UDI
Generic Name
Hevea-latex examination/treatment glove, non-powdered, antimicrobial FDA UDI
Device Name
Sterile Latex Surgical Gloves, Powder Free FDA UDI
Model / Reference
6.0 FDA UDI
Description
Sterile Latex Surgical Gloves, Powder Free FDA UDI

Identifiers

Primary DI / UDI-DI
09551006061010 FDA UDI
510(k) Number
K190241 FDA UDI
FDA Product Code
KGO FDA UDI
GMDN Term
Hevea-latex examination/treatment glove, non-powdered, 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

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: Hevea-latex examination/treatment glove, non-powdered, antimicrobial

Orcare Surgical Latex Pf by Careglove Global Sdn. Bhd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hevea-latex examination/treatment glove, non-powdered, antimicrobial.

Cleared under the same submission

K190241 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Careglove Global Sdn. Bhd.

Sources (1)

  • FDA UDI 68032a26-f68a-4ff3-97cd-1fb773dd0ca6 35 fields · synced Jun 1, 2026