Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013632692

FEI Number

3013632692

Entity Name

GUANGDONG COMFORT MEDICAL PRODUCTS CO., LTD.

City/State/Country

Jiangmen Guangdong, CN

Establishment Address

A26 District Three,Jiangmen Industrial, Transfer Industrial Park Enping District, Jiangmen Guangdong 529400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GuangDong Comfort Medical Products Co., Ltd. (Owner Number: 10055112)

Owner / Operator Contact Address

A26 District Three,Jiangmen Industrial, Transfer Industrial Park Enping District, Jiangmen, CN-GD 529400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

(Benzalkonium Chloride )BZK wipes; Adult Delay Wipes/Wipes for sex; Alcohol Prep Pads / Alcohol Towel / Wet Tissue /Medi GAUZE PADS Hydrogel Gauze,Hydrogel Medical Dressing Burn Dressing Burn Gel hot or cold pack SCAVENGING MASK, N95 MASK ELASTIC BANDAGE First aid kit without drug Disposable Nitrile Glove hot or cold pack EMERGENCY BLANKET ALCOHOL PAD SCISSORS gloves COTTON ROLL ICE BAG SAFETY PINS EYE PAD Cotton Balls Sterile ABSORBENT TIPPED APPLICATOR Eye Washing Solution; Nasal Saline Solution,saline Solution Splinter Remover TOURNIQUET, NONPNEUMATIC TWEEZERS CPR FACE SHIELD TONGUE DEPRESSOR Finger Splint Triangular Bandage ADHESIVE BANDAGE,ADHESIVE TAPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-12-29
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2017-06-21
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-12-29
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2018-03-15
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2017-06-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2017-06-21
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2017-06-21
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-09-29
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2017-06-21
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2017-06-21
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2017-06-21
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-06-21
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2017-06-21
EFN	Cotton, Roll	Dental	Class 1	872.6050	2017-06-21
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2017-06-21
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2017-06-21
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2017-06-21
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2024-12-29
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2017-06-21
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2024-07-18
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2024-12-29
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-12-29
KCX	Epilator, High Frequency, Tweezer-Type	General, Plastic Surgery	Class 1	878.5360	2017-06-21
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2024-12-29
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2017-06-21
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-12-29
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-06-08

Official Correspondent

Xiaoping Zhang

US Agent Details

Ruth Xu Business: First Aid And Health Products Inc. Email: maryleung9988@gmail.com Phone: (949) 6868291

Related Public Records

Same Entity

GuangDong Comfort Medical Products Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3008697511	Geann Industrial Co Ltd	Lukang Town Changhua, TW
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013632692. Last updated year: 2026. Please use registration number 3013632692 when referencing this establishment in official correspondence.