Model: PM3505RGN
DI: 06973062320543
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-24
Current Version: 2026-05-04
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d92252f2-9d1e-4179-bed8-9475814477f5
Distribution Status:
In Commercial Distribution
DUNS Number:
529796225
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06973062320543
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35091
Name: Surgical gown, single-use
Definition:
A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.
FDA Product Codes
FYA
Gown, Surgical
Premarket Submissions
Submission Number:
K222480
Supplement Number:
000