TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD

FDA Device Registration & Listing · Taizhou Jiangsu, CN · Registration 3005460813

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005460813
FEI Number
3005460813
Entity Name
TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD
City/State/Country
Taizhou Jiangsu, CN
Establishment Address
No. 18, Wuzhou (South) Road, Taizhou Jiangsu 225300, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Taizhou Xinkang Medical Materials Co., Ltd (Owner Number: 10045001)
Owner / Operator Contact Address
No. 18, Wuzhou (South) Road, Taizhou, CN-JS 225300, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

First Aid Kit First Aid Case First Aid Bag CPR-Aid Rescuer Device, Single Use VINYL PATIENT EXAMINATION GLOVES Isolation Gown, CPE Thumb Loop Isolation Gowns Disposable Nitrile Gloves, Nitrile Examination Gloves, Nitrile Gloves Zeolite Hemostatic Gauze Tracheotomy care kit Plastic Tweezers, Plastic Forceps Powder Free Nitrile Patient Examination Glove Nitrile Glove Polymer Patient Examination Glove Non-Powdered Patient Examination Glove Medical Nitrile Glove ABSORBENT TIP APPLICATOR: COTTON TIP APPLICATOR Sterile Abdominal Wound Dressing Pads Gauze Sponges, Non-woven Gauze Sponges, Conbine Pad, Multi-trauma Dressing, Abdominal Pad, Non-adherent Pad Triangular Bandage Eye Pad Face Mask, Mouth To Mouth Mask Skin Prep Tray Surgical Tape (Clear/Cloth/Non-Woven/Waterproof) 1/2"x2 1/2y, 1/2"x3y, 1/2"x5y, 1/2"x10y, 1"x 5y, 1"x10y Adhesive Bandage 2"x3", 3"x4", 4"x4", 4"x6", 4"x8" Bandage Fabric, butterfly wound closure, 3/4"x3", 1"x3", spot bandage, 2"x3", knee&elbow, fingertip, knuckle Transparent Dressing, Wound Closure Strips Bandage PE skin color 3/4"x3", 1"x3", junior bandage, spot bandage, 2"x3", knee&elbow First Aid Kit First Aid Case First Aid Bag Battery-powered medical examination light, Penlight MOUTH TO MOUTH MASK, CPR FACE SHIELD Alcohol Prep Pad, Alcohol Swab Sticks, Antiseptic Wipes, Normal Saline Wipe Povidone-lodine Swab Stick Cleaning Wipe, Soap Wipe, BZK Wipe: Povidone-lodine Prep Pad, Emergency Obstetrical Kit, OB Kit Gauze Bandage, Bandage Elastic Emergency Blanket, Emergency Sleeping Bag, Foil Baby bunting Tongue Depressor Polymer Patient Examination Glove Medical Nitrile Glove Non-Powdered Patient Examination Glove Nitrile Glove Powder Free Nitrile Patient Examination Glove Medical Scissors, Bandage Scissors, EMT Shears Kangzhu Cupping Set Pressure Cupping Set Cupping Set Saline Solution, Skin Wash Instant Ice Pack, Instant Cold Pack, Instant Hot Pack Wound Closure Strips, Wound Closure Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OHO First Aid Kit Without Drug General, Plastic Surgery Class 1 878.4014 2015-08-26
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2016-12-04
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2026-04-21
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2025-12-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-08-13
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-03-07
NXA Tracheotomy Care Kit Anesthesiology Class 2 868.5800 2025-12-11
HTD Forceps General, Plastic Surgery Class 1 878.4800 2019-02-12
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2026-01-08
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2019-02-12
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2013-09-10
ILI Sling, Arm Physical Medicine Class 1 890.3640 2013-09-10
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2016-02-25
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2016-08-03
OJU Skin Prep Tray General, Plastic Surgery Class 1 878.4800 2025-06-11
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2021-11-03
OHO First Aid Kit Without Drug General, Plastic Surgery Class 1 878.4014 2015-08-26
KYT Light, Examination, Medical, Battery Powered General Hospital Class 1 880.6350 2024-07-15
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2026-01-20
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2020-03-14
OKU Emergency Obstetrical Kit Obstetrics/Gynecology Class 1 884.4520 2021-01-21
FQM Bandage, Elastic General Hospital Class 1 880.5075 2013-09-10
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2013-09-10
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2022-05-05
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2026-01-08
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2024-05-23
KNM Device, Pressure Applying Physical Medicine Class 1 890.5765 2025-03-06
JCE Solution, Isotonic Pathology Class 1 864.4010 2024-12-25
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2019-02-12
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2022-08-18

Official Correspondent

Yujun Tang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Taizhou Xinkang Medical Materials 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
K052612 Shanghai Antares Industries, Inc. DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR 2005-11-22
K120584 Wealth on (Jiangsu) Co., Ltd. POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES 2012-07-10
K220992 Ever Global (Vietnam) Enterprise Corporation Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple 2022-10-19
K112610 Inpro Technology Device Factory SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) 2011-12-05
K131340 Made Plastic Co., Ltd. POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES 2014-09-09

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005460813. Last updated year: 2026. Please use registration number 3005460813 when referencing this establishment in official correspondence.
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