Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616874

FEI Number

3006403682

Entity Name

JIANERKANG MEDICAL CO., LTD.

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

No.1 Jianerkang Road, Industrial Zone, Zhixi Town, Jintan District, Changzhou City Jiangsu 213251, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JIANERKANG MEDICAL CO., LTD. (Owner Number: 9041776)

Owner / Operator Contact Address

No.1 Jianerkang Road, Industrial Zone, Zhixi Town, Jintan District, Changzhou City, CN-JS 213251, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232957

PMA Number

N/A

All Registered Proprietary Names

Gauze sponge, gauze swab, non woven sponge, conforming bandage, fluffy gauze bandage roll, fluffy gauze spong Dressing Pack for Heavy Drainage; Dressing Pad Combined Absorbent; Dry Wipes; gauze sponge; Gauze Swabs 100% Cotton Absorbent Gauze Roll 100% cotton; Burn Pad; Cotton Ball; Dental Roll 100% cotton; Dressing Pack for Heavy Drainage; Dressing Pack for Heavy Drainage; Dressing Pad Combined Absorbent; Dry Wipes; gauze sponge; Gauze Swabs 100% Cotton; CONTAINER, SPECIMEN, NON-STERILE Operating Room Towels Absorbent Patient Underpad GAUZE SPONGE, NON WOVEN SPONGE OR TOWEL, SURGICAL TOWEL OR TOWEL STERILE OR NON STERILE LUBRICANT PATIENT STERILE LUBRICATING JELLY Connecting tube suction tubing, connecting tube Bandage, liquid, skin protectant Sterile Lubricating Jelly Humidifier, Respiratory Gas, (Direct Patient Interface) AquaPak Humidifier Adapters; Aquapak Sterile Humidifier Reservoirs; AquaPak Bubble Prefilled Humidif Aquapak Prefilled Humidifier LAP SPONGE LAP SPONGE WITH X-RAY Lap Sponge - X-ray detectable HERMATIGE HOSPITAL PRO Sterile and Non-Sterile Ultrasound Gels; Media, Coupling, Ultrasound

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2002-05-16
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-04-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-11-04
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2025-09-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-09-06
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2004-08-10
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2025-06-19
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2021-06-25
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2019-01-04
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2012-06-15
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-03-21
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2000-06-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-03-01
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-09-06
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2024-05-13
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2024-02-18

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

JIANERKANG MEDICAL 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K861444	Surgical Specialties, Inc.	S1 NASAL PACKING	1986-05-06
K863737	Hermitage Hospital Products, Inc.	SPONGES STERILE TWIN PAKT AND SINGLES	1986-10-14
K940351	Certified Safety Mfg., Inc.	EXTRA LARGE COMPRESS DRESSING	1994-02-25
K950404	Lockett Medical Corp.	LOCKETT MEDICAL CORP. GAUZE	1995-04-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3013391391	HERKIMER COUNTY CHAPTER NYSARC, INC.	Herkimer, NY, US
3012677665	TECHNO PLASTICS INDUSTRIES, INC.	Anasco, PR, US
3038131023	UNITED TECHNOLOGY VIETNAM COMPANY LIMITED	Quang Ha Commune Quang Ninh, VN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3043106338	SHENZHEN SPONGE NEW MATERIAL CO. LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616874. Last updated year: 2026. Please use registration number 9616874 when referencing this establishment in official correspondence.