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Amerisource Bergen

FDA UDI

Class I (US FDA UDI)

by Bp Pharmaceuticals Laboratories Unlimited Company

Identity

Trade Name
Amerisource Bergen FDA UDI
Generic Name
Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Sterile Latex Surgical Gloves Size: 8.5 FDA UDI
Model / Reference
10116 FDA UDI
Description
Sterile Latex Surgical Gloves Size: 8.5 FDA UDI

Identifiers

Primary DI / UDI-DI
00368001101165 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hevea-latex surgical glove, non-powdered, non-antimicrobial

Amerisource Bergen by Bp Pharmaceuticals Laboratories Unlimited Company — 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bp Pharmaceuticals Laboratories Unlimited Company

Sources (1)

  • FDA UDI 0f72144f-3a75-4150-9c94-a26526f46065 33 fields · synced May 30, 2026