Device
(Newborn) Phototherapy Protective Mittens & Foot Covers
Manufacturer
Guangzhou Huiming Fibre Products Co., Ltd.
Guangzhou Huiming Fibre Products Co., Ltd.
Model: B101+B102
DI: 16979379450093
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
(Newborn) Phototherapy Protective Mittens & Foot Covers
Disposable neonatal phototherapy mittens and foot covers designed to protect infants' hands and feet from blue light exposure during phototherapy treatment.
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b59cd51f-8aa3-49ff-a7cc-59589f6f660d
Distribution Status:
In Commercial Distribution
DUNS Number:
526896695
Device Count:
2
DM Exempt:
No
Premarket Exempt:
Yes
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
Item #1 - Device ID:
26979379450090
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
500
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
16979379450093
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16979379450093
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
06979379450096
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 35492
Name: Isolation gown, single-use
Definition:
A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.
FDA Product Codes
FQM
Bandage, Elastic