Identity
- Trade Name
- Plasdent DuralProof Earloop Mask FDA UDI
- Generic Name
- Surgical/medical respirator, antimicrobial FDA UDI
- Device Name
- DuralProof(TM) Earloop Face Mask - Blue (50pcs/box) FDA UDI
- Model / Reference
- MK2 FDA UDI
- Description
- DuralProof(TM) Earloop Face Mask - Blue (50pcs/box) FDA UDI
Identifiers
- Catalog Number
- MK2-2 FDA UDI
- Primary DI / UDI-DI
- D832MK221 FDA UDI
- 510(k) Number
- K133070 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical respirator, antimicrobial 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical respirator, antimicrobial
Plasdent DuralProof Earloop Mask by Plasdent Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical/medical respirator, antimicrobial.
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Cleared under the same submission
K133070 also covers:
- Crosstex International — CROSSTEX INTERNATIONAL, INC.
- Crosstex International — CROSSTEX INTERNATIONAL, INC.
- Le Petit Masque — CROSSTEX INTERNATIONAL, INC.
- Procedure Face Mask with Ear Loop and Plastic Shield — Dynarex Corp.
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, INC.
- Essentials — HENRY SCHEIN, INC.
- Essentials — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Plasdent Corp.
Sources (1)
- FDA UDI bc1c6971-a359-44b7-842b-36ea3601c60d 35 fields · synced Jun 1, 2026