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Silicone Glove

FDA UDI

Class I (US FDA UDI)

by Hugh Steeper Limited

Identity

Trade Name
Silicone Glove FDA UDI
Generic Name
External limb prosthesis finishing component, non-customized FDA UDI
Model / Reference
EP GLOVE 7.75 LEFT MALE E5 FDA UDI

Identifiers

Catalog Number
TSG302/E5-EP FDA UDI
Primary DI / UDI-DI
05055348297273 FDA UDI
FDA Product Code
IPM FDA UDI
GMDN Term
External limb prosthesis finishing component, non-customized FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External limb prosthesis finishing component, non-customized

A comprehensive medical device for providing an aesthetic outer shape and surface to upper or lower limb prostheses. It is designed to provide protection from external agents such as debris, water splashes, impact forces.

Similar devices

Also classified as External limb prosthesis finishing component, non-customized.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hugh Steeper Limited

Sources (1)

  • FDA UDI 97e3987f-75ce-49b6-9149-0753563a5fe0 33 fields · synced Jun 27, 2026