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Polysilk

FDA UDI

Class I (US FDA UDI)

by Shamrock Marketing Co.

Identity

Trade Name
Polysilk FDA UDI
Generic Name
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Shamrock 18000 Black Latex Examination Powder Free Textured Gloves, Xlarge FDA UDI
Model / Reference
18014 FDA UDI
Description
Shamrock 18000 Black Latex Examination Powder Free Textured Gloves, Xlarge FDA UDI

Identifiers

Primary DI / UDI-DI
00641932180141 FDA UDI
510(k) Number
K062709 FDA UDI
FDA Product Code
LYY FDA UDI
GMDN Term
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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 examination/treatment glove, non-powdered, non-antimicrobial

Polysilk by Shamrock Marketing Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K062709 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shamrock Marketing Co.

Sources (1)

  • FDA UDI 965ff701-416b-472f-bf2c-72e7af738ac2 34 fields · synced Jun 1, 2026