510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101593Substantially Equivalent

Emm Surgical Gown-Sms with Pe Layer, Model 18-501 L, 18-501-Xl, 18-501 Xxl, 18-501-Xlxl

Exact Medical Manufacturing, Inc., Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101593 is the FDA 510(k) clearance record for EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL, a class II device, cleared for Exact Medical Manufacturing, Inc. on under FDA product code FYA (Gown, Surgical). FDA records list 9 510(k) clearances for Exact Medical Manufacturing, Inc., from to . As of , FDA records show no recalls naming K101593.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Exact Medical Manufacturing, Inc. 1083 Delaware Ave., Buffalo NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260