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Sempermed Syntegra UV Polyisoprene Surgical Glove

FDA UDI

by Sempermed Usa, Inc.

Identity

Trade Name
Sempermed Syntegra UV Polyisoprene Surgical Glove FDA UDI
Generic Name
Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Sempermed Syntegra UV Polyisoprene Surgical Glove, size 6.5 FDA UDI
Model / Reference
SUV650 FDA UDI
Description
Sempermed Syntegra UV Polyisoprene Surgical Glove, size 6.5 FDA UDI

Identifiers

Catalog Number
SUV650 FDA UDI
Primary DI / UDI-DI
00841277105742 FDA UDI
510(k) Number
K191860 FDA UDI
FDA Product Code
OPA FDA UDI
KGO FDA UDI
GMDN Term
Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI

Classification

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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Sempermed Syntegra UV Polyisoprene Surgical Glove by Sempermed Usa, Inc. — 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

K191860 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sempermed Usa, Inc.

Sources (1)

  • FDA UDI 2f6fb949-ab57-44f6-9b0d-2632291e3ea3 36 fields · synced Jun 1, 2026