CautionWear Iron Grip

FDA UDI

Class II (US FDA UDI)

by Caution Wear Corp.

Identity

Trade Name: CautionWear Iron Grip FDA UDI
Generic Name: Basic male condom, Hevea-latex FDA UDI
Device Name: Male Latex Condom, Parallel-Sided, Smooth Surface, Snugger Fit (49 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket. FDA UDI
Model / Reference: CW0001IG FDA UDI
Description: Male Latex Condom, Parallel-Sided, Smooth Surface, Snugger Fit (49 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850836007212 FDA UDI
510(k) Number: K002393 FDA UDI
FDA Product Code: HIS FDA UDI
GMDN Term: Basic male condom, Hevea-latex FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Basic male condom, Hevea-latex

CautionWear Iron Grip by Caution Wear Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K002393 also covers:

CautionWear Classic — Caution Wear Corp.
CautionWear PPE — Caution Wear Corp.
FPA — Caution Wear Corp.
Prudence Classic — DKT de México, S.A. de C.V.
Prudence Classic — DKT de México, S.A. de C.V.
Caution Wear — LUNAMAX LLC
Caution Wear — LUNAMAX LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Caution Wear Corp.

Sources (1)

FDA UDI 1e4c98fc-bb8a-4ce9-bfc2-ec299272c612 36 fields · synced May 30, 2026