510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901667Substantially Equivalent

Latex Condoms - Code No. 401, 421 & 1002

Allercare/Nsl, Inc., Lincolnwood IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901667 is the FDA 510(k) clearance record for LATEX CONDOMS - CODE NO. 401, 421 & 1002, a class II device, cleared for Allercare/Nsl, Inc. on under FDA product code HIS (Condom). FDA records list 4 510(k) clearances for Allercare/Nsl, Inc. As of , FDA records show no recalls naming K901667.

Clearance record

Decision date
Received
(36 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Allercare/Nsl, Inc. 7150 N. Ridgeway, Lincolnwood IL
Third party review
No

Clearances, product code HIS

Trailing 12 months
3 clearances under product code HIS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260