Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008386507

FEI Number

3008386507

Entity Name

H&K INTERNATIONAL TRADE LIMITED (CHINA)

City/State/Country

jinhua Zhejiang, CN

Establishment Address

15th floor, tower B, international plaza, 518, shuanglong south road, jinhua Zhejiang 321017, CN

Establishment Type(s)

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

Owner / Operator

H&K International Trade Limited (China) (Owner Number: 10032555)

Owner / Operator Contact Address

15th floor, tower B, international plaza, 518, shuanglong south road, jinhua, CN-ZJ 321017, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ABD pad PBT bandage 5cm*4.5m Cohesive bandage Bandages PBT bandage 7.5cm*4.5m PBT bandage 6cm*4m drive medical OLLIE'S BARGAIN OUTLET First Aid Kit Eye pad PE adhesive plaster 76*45mm medical tape 1.25cm*5m PE adhesive plaster 76*19mm PE adhesive plaster 10*45mm Bandage Triangulaire medical tape 2.5cm*5Y PE adhesive plaster 76*25mm PE adhesive plaster 76*38mm PE adhesive plaster 56*19mm PE adhesive plaster 40*10mm medical tape 1.25cm*5y PE adhesive plaster 50*100mm gloves First aid kit Silver emergency blanket 130*210cm Cotton swab Wound dressing Wound patch Disposable CPR Mask Moleskin Blister Pad tongue depressor tweezers 8.9cm tick remover tweezers 12.5cm tourniquet 2.5*45cm scissors 13cm scissors 9cm Guaze swabs 10*10cm Guaze swabs 5*5cm gauze safety pins 10pcs safety pins 5pcs Burn Dressing Burn Gel Packet mask drive medical mask swim goggles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2023-08-17
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-08-10
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2010-05-24
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2023-08-10
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2023-08-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-08-17
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2023-08-17
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2023-08-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-08-17
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2023-08-10
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-08-17
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2023-08-10
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2023-08-17
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2023-08-17
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2023-08-10
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2023-08-10
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2023-08-17
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-08-17
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-08-10
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2023-08-17
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2023-08-17
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-08-23
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2012-02-20
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2023-08-17
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2022-12-16

Official Correspondent

Jaken Mei

US Agent Details

shally dream Email: mljyangguang@msn.com Phone: (202) 2905340

Related Public Records

Same Entity

H&K International Trade Limited (China)

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008388419	Jinhua Twinstar Tools Co. Ltd	jinhua Zhejiang, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

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

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3021282544	DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD	Dongyang Zhejiang, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008386507. Last updated year: 2026. Please use registration number 3008386507 when referencing this establishment in official correspondence.