Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015422337

FEI Number

3015422337

Entity Name

XIAMEN FIRSTCARE IMP. & EXP. CO.,LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

602-1, Bldg. 2A, Torch Xinke Plaza, No.2 Weili Road, Xiamen Fujian 361015, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Xiamen FirstCare Imp. & Exp. Co.,ltd. (Owner Number: 10062096)

Owner / Operator Contact Address

602, No.786, East Lian Qian Road, Siming District, Xiamen, CN-FJ 361000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silicone Massage Cup Pressure Applying - Kangzhu Cupping Kit Silicone Cupping Set AIRWAY, NASOPHARYNGEAL NASOPHARYNGEAL AIRWAY Nitrile Gloves Non-Sterile Blue Color Patient Nitrile Examination Gloves Powder Free NON-CONTACT INFRARED THERMOMETER NON-CONTACT DIGITAL THERMOMETER IR Thermometer JXB-178 Infrared Thermometer Reusable Penlight Disposable Penlight Plastic Penlight Aluminum Penlight TAPE AND BANDAGE, ADHESIVE Adhesive Bandages Wound Closure Device ZZIPS ZZIPS CUT KIT ZZIPS 2 PACK Silver Alginate Dressing Emergency Blanket Emergency Foil Blanket Emergency Space Blanket Mylar Blanket NON-PRESCRIPTION SUNGLASSES Sunglasses with Impact Resistant Lenses First Aid Kit without drug Empty First Aid Box First Aid Kit Bag with CPR Face Shield Empty First Aid Bag Metal First Aid Kit Box OXYGEN MASK CPR Face Shield Face Shield CPR Mask without Oxygen Port Infant CPR Mask without Oxygen Port CPR Mask with Oxygen Port Non-Rebreathing Valve (18.5mm) Non-Rebreathing Valve (15mmOD) Gauze Pad Medical Nitrile Glove Polymer Patient Examination Glove Non-Powdered Patient Examination Glove Powder Free Nitrile Patient Examination Glove Nitrile Glove Tongue Depressor Non-Surgical Tongue Depressor Depressor Compressed Krinkle Gauze Compressed Gauze Emergency Pressure Bandage Blood Pressure Meter Model Max0203 (Blue, Pink or Black cuff) Polymer Patient Examination Glove Nitrile Patient Examination Glove Nitrile Medical Glove Elastic Bandage Alcohol prep pad Antiseptic wipes Alcohol swab sticks Antiseptic cleaning wipe Oropharyngeal Anesthesiology - Oropharyngeal Airway Airway Disposable Isolation Gowns INSTANT COLD PACK Disposable Hot or Cold Pack Hot or Cold Pack Disposable INSTANT HOT PACK Aluminum Crutches

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2019-12-18
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2020-11-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-12-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-12
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2024-07-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-10-29
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	2022-06-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-03-02
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-01-13
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2020-09-07
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2019-12-18
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2020-10-29
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2020-10-25
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-12-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-01-08
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2022-07-02
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2022-01-27
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2020-10-26
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2020-10-26
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-03-06
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-03-06
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-03-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-03-06
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2021-12-12
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-11-25
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2019-12-17
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-07
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2020-11-17
IPR	Crutch	Physical Medicine	Class 1	890.3150	2022-02-17

Official Correspondent

QINGHONG GU

US Agent Details

ESTHER LIU Email: us_agent@fdaclass.com Phone: (404) 9323207

Related Public Records

Same Entity

Xiamen FirstCare Imp. & Exp. 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
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
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

Similar Registrations

Registration Number	Establishment Name	Location
9612390	Wujiang City Shen Ling Medical Device Co.,Ltd.	Suzhou Jiangsu, CN
3010673773	Ningbo Troika Science & Technology Co.,Ltd.	Ningbo Zhejiang, CN
3013397886	ADVANCE-ESTHETIC LLC	Fort Lauderdale, FL, US
3033450607	DONGGUAN XILIJIAN TECHNOLOGY CO., LTD.	Dongguan Guangdong, CN
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015422337. Last updated year: 2026. Please use registration number 3015422337 when referencing this establishment in official correspondence.