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S&J

FDA UDI

Class II (US FDA UDI)

by Xiantao S&J Protective Products Co., Ltd

Identity

Trade Name
S&J FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
Disposable Medical Face Mask Level 2 (Non-Sterile) FDA UDI
Model / Reference
M2223 FDA UDI
Description
Disposable Medical Face Mask Level 2 (Non-Sterile) FDA UDI

Identifiers

Primary DI / UDI-DI
06974960062238 FDA UDI
510(k) Number
K211462 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical/medical face mask, non-antimicrobial, single-use

S&J by Xiantao S&J Protective Products Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, non-antimicrobial, single-use.

Cleared under the same submission

K211462 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xiantao S&J Protective Products Co., Ltd

Sources (1)

  • FDA UDI d4bd9bf7-d3cd-4303-a6dd-476b99334718 34 fields · synced Jun 20, 2026