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Male Latex Condoms 53mm, condom(Dotted)

by Shanghai Personage Hygiene Products Co., Ltd. 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06936296747623 UDI-DI Date23 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Male Latex Condoms
Generic Name
Basic male condom, Hevea-latex
Model / Reference
53mm, condom(Dotted)
Primary DI / UDI-DI
06936296747623
510(k) Number
FDA Product Code
HIS
GMDN Term
Basic male condom, Hevea-latex
Device Class
Class II
Regulation Number
884.5300
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K220576)

Show all (12)

Other devices from Shanghai Personage Hygiene Products Co., Ltd.

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Properties

  • Single Use
  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No