← Back to catalogue

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
6.5 FDA UDI
Description
Sterile Latex Surgical Gloves, Powder Free FDA UDI

Identifiers

Primary DI / UDI-DI
09551006060426 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Careglove Global Sdn. Bhd.

Sources (1)

  • FDA UDI 139bdff4-7d7f-4b63-a693-6afd6190445c 35 fields · synced Jun 6, 2026