Is this your brand? Sign in to claim ownership.
Sign in to claim this brandLac Mac, Ltd.
US
Last updated May 23, 2026
What Lac Mac, Ltd. makes
Lac Mac, Ltd. manufactures reusable surgical gowns, patient surgical drapes, and sterilization packaging designed for medical and isolation use. Their products are intended for single-use alternatives in sterile procedures, including operating room and critical care environments.
The company’s reusable products are classified under FDA regulations as Class I and Class II devices, with some models listed via the 510(k) and UDI pathways. Lac Mac, Ltd. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Lac Mac, Ltd. manufacture?
Lac Mac, Ltd. specializes in reusable medical textiles for sterile environments, including surgical gowns, patient surgical drapes, sterilization packaging, and isolation gowns. These products are designed to replace single-use alternatives in settings like operating rooms and critical care areas, ensuring compliance with sterile procedure requirements.
Where is Lac Mac, Ltd. based, and how does that affect its regulatory standing?
Lac Mac, Ltd. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s device categories and potential listing via pathways like the 510(k) or UDI system.
How are Lac Mac, Ltd.’s devices classified under FDA regulations?
Lac Mac, Ltd.’s reusable medical textiles fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls or performance standards. The classification determines regulatory requirements, such as pre-market notifications (e.g., 510(k)) or post-market surveillance.
Which regulatory registries or databases list Lac Mac, Ltd.’s devices?
Lac Mac, Ltd.’s devices are documented in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries help track authorized medical devices, ensuring transparency in compliance and market availability. The 510(k) pathway is used for devices requiring pre-market clearance, while UDI provides standardized identification for post-market tracking.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (246)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lac-Mac | 005XEAC-M | FDA UDI | Class II | Active |
| Lac-Mac | 005XEAK-S | FDA UDI | Class II | Active |
| Lac-Mac | 084E-TK | FDA UDI | Class II | Active |
| Lac-Mac | 035CNAA | FDA UDI | Class II | Active |
| Lac-Mac | 005XXAE-S | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAE-3XL | FDA UDI | Class II | Active |
| Lac-Mac | 026XGAK | FDA UDI | Class II | Active |
| Lac-Mac | 005XF-XL | FDA UDI | Class II | Active |
| Lac-Mac | 092E-IY | FDA UDI | Class II | Active |
| Lac-Mac | 005XH-L | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAP-L | FDA UDI | Class II | Active |
| Lac-Mac | 005XXCA-XL | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAN-L | FDA UDI | Class II | Active |
| Lac-Mac | 005XEAB-S | FDA UDI | Class II | Active |
| Lac-Mac | 084W-FM | FDA UDI | Class II | Active |
| Lac-Mac | 005XXAE-3XL | FDA UDI | Class II | Active |
| Lac-Mac | 92E-IT | FDA UDI | Class II | Active |
| Lac-Mac | 005XX-L | FDA UDI | Class II | Active |
| Lac-Mac | 005XPAB-M | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAJ-4XL | FDA UDI | Class II | Active |
| Lac-Mac | 084E-AF | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAN-XL | FDA UDI | Class II | Active |
| Lac-Mac | 005XEAG-XL | FDA UDI | Class II | Active |
| Lac-Mac | 025XNAA | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAB-L | FDA UDI | Class II | Active |
| Lac-Mac | 005XEAG-2XL | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAB-XL | FDA UDI | Class II | Active |
| Lac-Mac | 005XXAE-L | FDA UDI | Class II | Active |
| Lac-Mac | 026YUAE | FDA UDI | Class II | Active |
| Lac-Mac | 025ZS | FDA UDI | Class II | Active |
| Lac-Mac | 92E-IF | FDA UDI | Class II | Active |
| Lac-Mac | 084E-GA | FDA UDI | Class II | Active |
| Lac-Mac | 005XE-2XL | FDA UDI | Class II | Active |
| Lac-Mac Limited | 084E-JK | FDA UDI | Class II | Active |
| Lac-Mac | 025YF | FDA UDI | Class II | Active |
| Lac-Mac | 005ABAM-S | FDA UDI | Class II | Active |
| Lac-Mac | 026XJ | FDA UDI | Class II | Active |
| Lac-Mac | 091XSAB | FDA UDI | Class II | Active |
| Lac-Mac | 026YQ | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAH-3XL | FDA UDI | Class II | Active |
| Lac-Mac | 025XNAE | FDA UDI | Class II | Active |
| Lac-Mac | 005ABAM-XL | FDA UDI | Class II | Active |
| Lac-Mac | 025XD | FDA UDI | Class II | Active |
| Lac-Mac | 005XEAA-L | FDA UDI | Class II | Active |
| Lac-Mac | 084W-AX | FDA UDI | Class II | Active |
| Lac-Mac | 084W-AS | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAH-L | FDA UDI | Class II | Active |
| Lac-Mac | 005XFAO-2XL | FDA UDI | Class II | Active |
| Lac-Mac | 005XXCE-M | FDA UDI | Class II | Active |
| Lac-Mac | 005XXBN-XL | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Lac-Mac Limited LONDON Ontario · CA FEI 6499