510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K871948Substantially Equivalent

Angel Latex Prophylactics (Condoms)

Angel Intl. Trading Co., Inc., Cameron TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871948 is the FDA 510(k) clearance record for ANGEL LATEX PROPHYLACTICS (CONDOMS), a class II device, cleared for Angel Intl. Trading Co., Inc. on under FDA product code HIS (Condom). FDA records list one 510(k) clearance for Angel Intl. Trading Co., Inc. As of , FDA records show no recalls naming K871948.

Clearance record

Decision date
Received
(153 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Angel Intl. Trading Co., Inc. U.S. Hwy. 190 And Colfax St., Cameron TX
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