Identity
- Trade Name
- Lac-Mac FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size 3XL FDA UDI
- Model / Reference
- 005DSBK-3XL FDA UDI
- Description
- Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size 3XL FDA UDI
Identifiers
- Catalog Number
- 005DSBK-3XL FDA UDI
- Primary DI / UDI-DI
- 00627755571168 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation gown, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 54 Inch FDA UDI
Category: Isolation gown, reusable
Lac-Mac by Lac Mac, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isolation gown, reusable.
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
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- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- ComPel Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- HENRY SCHEIN — HENRY SCHEIN, INC. · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Lac Mac, Ltd.
Sources (1)
- FDA UDI 136ab4d0-1a92-4a02-b027-74f4005e7466 36 fields · synced May 30, 2026