510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K212037Substantially Equivalent

SancDam Latex Oral Dam

Sanctuary Health Sdn Bhd, Chemor, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212037 is the FDA 510(k) clearance record for SancDam Latex Oral Dam, a class II device, cleared for Sanctuary Health Sdn. Bhd. on under FDA product code MSC (Barrier, Std, Oral Sex). FDA records list one 510(k) clearance for Sanctuary Health Sdn. Bhd. As of , FDA records show no recalls naming K212037.

Clearance record

Decision date
Received
(271 days to decision)
Product code
MSC Barrier, Std, Oral Sex
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sanctuary Health Sdn. Bhd. # 16, Persiaran Perindustrian Kanthan 1, Kawasan, Chemor, MY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSC

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