510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902324Substantially Equivalent

Tp and Design, Condom

China National Medicines & Health Prod. I/E Corp., Scarsdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902324 is the FDA 510(k) clearance record for TP AND DESIGN, CONDOM, a class II device, cleared for China National Medicines & Health Prod. I/E Corp. on under FDA product code HIS (Condom). FDA records list 12 510(k) clearances for China National Medicines & Health Prod. I/E Corp., from to . As of , FDA records show no recalls naming K902324.

Clearance record

Decision date
Received
(309 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
China National Medicines & Health Prod. I/E Corp. Lackenbach Siegel Marzullo, Scarsdale NY
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