510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212338Substantially Equivalent

SterileRight sterilization pouch and roll

Sterileright Packaging Mfg Inc., Keelung City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212338 is the FDA 510(k) clearance record for SterileRight sterilization pouch and roll, a class II device, cleared for Sterileright Packaging Mfg., Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list one 510(k) clearance for Sterileright Packaging Mfg., Inc. As of , FDA records show no recalls naming K212338.

Clearance record

Decision date
Received
(97 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Sterileright Packaging Mfg., Inc. 1f, #33-7, Dahua 2nd Rd., Qidu Dist., Keelung City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRG

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