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Makrite Industries Inc.

FDA UDI

Class II (US FDA UDI)

by Makrite Hubei Industrial Co., Ltd.

Identity

Trade Name
Makrite Industries Inc. FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
FDA cleared ASTM Level 3 earloop surgical face mask, regular size. FDA UDI
Model / Reference
M663BE FDA UDI
Description
FDA cleared ASTM Level 3 earloop surgical face mask, regular size. FDA UDI

Identifiers

Primary DI / UDI-DI
06973875280775 FDA UDI
510(k) Number
K220550 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Makrite Industries Inc. by Makrite Hubei Industrial 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

K220550 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Makrite Hubei Industrial Co., Ltd.

Sources (1)

  • FDA UDI 952bb95f-9376-470f-bcb4-d6eea2369f81 34 fields · synced May 30, 2026