Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011434305

FEI Number

3011434305

Entity Name

XIANTAO S&J PROTECTIVE PRODUCTS CO., LTD

City/State/Country

Xiantao Hubei, CN

Establishment Address

18 Zhijin Road, Pengchang, Xiantao Hubei 433000, CN

Establishment Type(s)

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

Owner / Operator

Xiantao S&J Protective Products Co., Ltd (Owner Number: 10058294)

Owner / Operator Contact Address

18 Zhijin Road, Pengchang, Xiantao, CN-HB 433000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tray cover; Air/water syringe sleeve; Barrier film; Bendable applicator brush; Bib holder; Clear curing light cover; T-bar light handle cover; X-ray head sleeve Digital sensor cover; Half chair sleeve; Handpiece sleeve; Headrest cover; Indicator strips; Indicator tape Intraoral camera sleeve; Micro Brush Applicators; Paper wrapper; Paper/poly pouches; Plastic Prophy; Barrier envelopes Barrier Sleeves Disposable Face Mask, KN95 Protective Face Mask, KF94 Protective Face Mask Mouthpiece, Saliva Ejector Alcohol Pad, Hand Sanitizer, Medical Alcohol, Medical Devices Sanitizer Spray, Antiseptic Towelette Surgical Drape, Keyboard Cover Face Shields; Goggles; Safety Goggles; Spectacles Emesis Bag; Emesis Bag Dispenser Elastic Bandage; Gauze Bandage DEPRESSOR, TONGUE, NON-SURGICAL Lab Coats, Lab Jackets, Patient Gown, Scrub Suit, Visitor Gown, Disposable Shorts Disposable Dental Kits, Oral Care Kits, Personal Hygiene Kits Surgical Face Mask, Medical Face Mask Gloves, Oversleeves, PE Oversleeves, Bouffant Cap, Clip Cap/Mob Cap, Surgeon Cap/Doctor Cap Photographic Mirror; Mouth Mirror Dental Retractor Cotton Tip Applicators Gauze sponge, X-ray detectable sponge, Cotton filled sponges Disposable Apron, Non-woven Apron, PE Apron, CPE Apron Gutta Percha Points Denture Box; Retainer Box; Measure Cups Adhesive bandage Air/Water Syringe Tips, Curved Utility Syringes Dental Needle Oral Vented Evacuation Tips Absorbent Paper Points Micro Applicators Prophy Cup; Prophy Brush; Prophy Angles, Dappen Dishes Face Mask, Disposable Face Mask, Pleated Mask Shoe Cover HP Mixing Tips, Intra Oral Tips, Dispensing Guns Toothbrush, Manual Impression Trays - Dental, Bite Registration Trays, Fluoride Trays Pre Bent Needles, Flow Tips, Irrigation Syringes with Curved Tip Nonwoven Sponge, Nonwoven Gauze, Nonwoven Roll, Gelatin Hemostatic Sponge Plastic Instrument Tray, Plastic Dental Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2021-11-16
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2021-11-16
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-05-01
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2022-11-06
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-07-31
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-11-16
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-11-06
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2023-08-23
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2022-11-07
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2021-11-16
FME	Gown, Examination	General Hospital	Class 1	880.6265	2018-11-26
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-08-07
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2018-11-26
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2022-11-06
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2022-11-07
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2021-11-16
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2021-11-16
IWO	Apron, Protective	Radiology	Class 1	892.6500	2022-09-29
EKM	Gutta-Percha	Dental	Class 1	872.3850	2024-09-12
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-04-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-11-16
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2022-11-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2024-09-12
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2021-11-16
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2024-09-12
KXR	Applicator, Resin	Dental	Class 1	872.3140	2021-11-16
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2022-11-06
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2019-04-29
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2019-04-29
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2025-02-21
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-11-16
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2021-11-16
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2024-09-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-11-16
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-11-16

Official Correspondent

Ge Wei

US Agent Details

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

Related Public Records

Same Entity

Xiantao S&J Protective 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011434305. Last updated year: 2026. Please use registration number 3011434305 when referencing this establishment in official correspondence.