Xiantao S&J Protective Products Co., Ltd.
Manufacturer and brand owner in Xiantao, Hubei, China. 41 device types, 4 products catalogued, 1 clearance.
Xiantao S&J Protective Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cotton, Roll, Gutta-Percha and 39 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
41device types registered with the FDA
4products catalogued under its own name
1510(k) clearance
Registration
| Registered name | XIANTAO S&J PROTECTIVE PRODUCTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011434305 |
| FEI number | 3011434305 |
| DUNS | 554445746 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | 18 Zhijin Road, Pengchang |
| Postal code | 433000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Patient Bibs, Crepe Paper, CSR Wrap | 2021 | 86 |
| Accessories, Retractor, Dental | Class 1 | Dental Retractor | 2022 | 37 |
| Accessory, Surgical Apparel | Class 1 | Gloves, Oversleeves, PE Oversleeves, Bouffant Cap, Clip Cap/Mob Cap, Surgeon Cap/Doctor Cap | 2018 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Tip Applicators | 2021 | 186 |
| Applicator, Resin | Class 1 | Micro Applicators | 2021 | 24 |
| Apron, Protective | Class 1 | Disposable Apron, Non-woven Apron, PE Apron, CPE Apron | 2022 | 46 |
| Basin, Emesis | Class 1 | Emesis Bag; Emesis Bag Dispenser | 2023 | 65 |
| Bedding, Disposable, Medical | Class 1 | Bedsheet, Bed Sheet Roll, Bedcover, Pillowcase, Body Bag, Underpad, Crepe Paper Roll, Drape Sheet, Table Cover | 2019 | 308 |
| Chair, Dental, Without Operative Unit | Class 1 | Barrier Sleeves | 2021 | 38 |
| Cotton, Roll | Class 1 | Cotton Roll | 2021 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe Cover | 2019 | 176 |
| Cup, Prophylaxis | Class 1 | Prophy Cup; Prophy Brush; Prophy Angles, Dappen Dishes | 2022 | 49 |
| Depressor, Tongue, Non-Surgical | Class 1 | Depressor, Tongue, NON-Surgical | 2021 | 100 |
| Disinfectant, Medical Devices | Class 1 | Alcohol Pad, Hand Sanitizer, Medical Alcohol, Medical Devices Sanitizer Spray, Antiseptic Towelette | 2023 | 197 |
| Drape, Surgical, Exempt | Class 2 | Surgical Drape, Keyboard Cover | 2021 | 107 |
| Dressing, Compression | Class 1 | Elastic Bandage; Gauze Bandage | 2022 | 87 |
| Evacuator, Oral Cavity | Class 1 | Oral Vented Evacuation Tips | 2021 | 49 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Disposable Face Mask, KN95 Protective Face Mask, KF94 Protective Face Mask | 2020 | 182 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Nonwoven Sponge, Nonwoven Gauze, Nonwoven Roll, Gelatin Hemostatic Sponge | 2021 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Gauze sponge, X-ray detectable sponge, Cotton filled sponges | 2021 | 67 |
| Gown, Examination | Class 1 | Lab Coats, Lab Jackets, Patient Gown, Scrub Suit, Visitor Gown, Disposable Shorts | 2018 | 109 |
| Gutta-Percha | Class 1 | Gutta Percha Points | 2024 | 42 |
| Instrument, Manual, Surgical, General Use | Class 1 | Denture Box; Retainer Box; Measure Cups | 2023 | 110 |
| Instruments, Dental Hand | Class 1 | Disposable Dental Kits, Oral Care Kits, Personal Hygiene Kits | 2025 | 64 |
| Mask, Scavenging | Class 1 | Face Mask, Disposable Face Mask, Pleated Mask | 2019 | 158 |
| Mask, Surgical | Class 2 | Surgical Face Mask, Medical Face Mask | 2021 | 125 |
| Mirror, Mouth | Class 1 | Photographic Mirror; Mouth Mirror | 2022 | 94 |
| Mouthpiece, Saliva Ejector | Class 1 | Mouthpiece, Saliva Ejector | 2022 | 68 |
| Needle, Dental | Class 1 | Dental Needle | 2024 | 56 |
| Non-Surgical Gown | Class 1 | Isolation Gown, Non-Surgical Isolation Gown, CPE Gown | 2021 | 318 |
| Point, Paper, Endodontic | Class 1 | Absorbent Paper Points | 2024 | 35 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Face Shields; Goggles; Safety Goggles; Spectacles | 2022 | 384 |
| Suit, Surgical | Class 1 | Surgical Gown, Coverall | 2021 | 74 |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | Pre Bent Needles, Flow Tips, Irrigation Syringes with Curved Tip | 2024 | 32 |
| Syringe, Restorative And Impression Material | Class 1 | HP Mixing Tips, Intra Oral Tips, Dispensing Guns | 2025 | 49 |
| Tape And Bandage, Adhesive | Class 1 | Adhesive bandage | 2021 | 353 |
| Toothbrush, Manual | Class 1 | Toothbrush, Manual | 2021 | 244 |
| Tray, Impression, Preformed | Class 1 | Impression Trays – Dental, Bite Registration Trays, Fluoride Trays | 2021 | 73 |
| Tray, Surgical, Instrument | Class 1 | Plastic Instrument Tray, Plastic Dental Tray | 2021 | 105 |
| Unit, Operative Dental, Accessories | Class 1 | Tray cover; Air/water syringe sleeve; Barrier film; Bendable applicator brush; Bib holder; Clear curing light cover;, 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, T-bar light handle cover; X-ray head sleeve | 2021 | 65 |
| Unit, Syringe, Air And/Or Water | Class 1 | Air/Water Syringe Tips, Curved Utility Syringes | 2022 | 56 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211462 | 2021-08-19 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Employees | 150+ |
| Factory area | 63,000 square meters with Class 8 Cleanrooms |
| Main products | Surgical face masks, Isolation gowns, Lab coats, Dental bibs, Sterilization pouches |
| Certifications | CE MDR, FDA 510(k), ISO 13485, FSC, TGA |
| Export markets | 90% exported worldwide |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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