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Biogel® PI OrthoPro

FDA UDI

Class I (US FDA UDI)

by Mölnlycke Health Care AB

Identity

Trade Name
Biogel® PI OrthoPro FDA UDI
Generic Name
Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Biogel PI OrthoPro 7.0x40 FDA UDI
Model / Reference
47670 FDA UDI
Description
Biogel PI OrthoPro 7.0x40 FDA UDI

Identifiers

Primary DI / UDI-DI
07332551976071 FDA UDI
510(k) Number
K112257 FDA UDI
FDA Product Code
KGO FDA UDI
GMDN Term
Polyisoprene 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polyisoprene surgical glove, non-powdered, non-antimicrobial

Biogel® PI OrthoPro by Mölnlycke Health Care AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyisoprene surgical glove, non-powdered, non-antimicrobial.

Cleared under the same submission

K112257 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mölnlycke Health Care AB

Sources (1)

  • FDA UDI e10a5a87-bbfa-4261-b227-a68fbfd50ae5 36 fields · synced Jun 8, 2026