# K243721: Self Sealing Sterilization Pouches

- Pathway: 510(k) (Traditional)
- Applicant: Wellmed Dental Medical Supply Co., Ltd.
- Decided: Apr 25, 2025 after 143 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows: » Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads. * Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%- 90%:; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F). The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch’s external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization. Table of Maximum load: Maximum load Product code Specification (Inch. ) Gauze Plastic Metal SP-001-MP 2.25"x4" 2¢ 13g 17g SP-57152-MP 2.25" x6" 2.5¢ l4g 18g SP-003-MP 2"x7.75" 15g 18g 20g SP-004-MP 2.75"x10" 31g 36g 40g SP-005-MP 3.5"x5.25" 45g 49g S54g SP-006-MP 3.5"x10" 50g 60g 130g SP-007A-MP 5.25"x10" 204g 208g 217g SP-007-MP 5.25"x 11" 208g 213g 226g SP-190330-MP 7.5"x13" 226g 320g 460g SP-008-MP 7.5" x14" 249¢ 353g 510g SP-190405-MP ~ 7.5"x 16" 250g 380g 550g SP-009-MP 9"x15" 270g 460g 680g SP-010-MP 9.8"x15.75" 281g 580g 775g SP-011-MP 9"x16" 275g 510g 580g

Source page: https://510kreport.com/device/K243721
Methodology: https://510kreport.com/methodology