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Customed

FDA UDI

Class I (US FDA UDI)

by Customed, Inc.

Identity

Trade Name
CUSTOMED FDA UDI
Generic Name
Hevea-latex surgical glove, powdered FDA UDI
Device Name
CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 8 FDA UDI
Model / Reference
712057693051 FDA UDI
Description
CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 8 FDA UDI

Identifiers

Catalog Number
9003051 FDA UDI
Primary DI / UDI-DI
M20890030517 FDA UDI
510(k) Number
K010198 FDA UDI
FDA Product Code
KGO FDA UDI
GMDN Term
Hevea-latex surgical glove, powdered 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

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

Yes

FDA UDI

Dimensions & Sizes

Size
Circumference — 8.0 Inch FDA UDI

Category: Hevea-latex surgical glove, powdered

Customed by Customed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hevea-latex surgical glove, powdered.

Cleared under the same submission

K010198 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Customed, Inc.

Sources (1)

  • FDA UDI 4f2130e4-6bc4-42c7-9136-051efe4aa27c 38 fields · synced May 30, 2026