FDA.reportPublic FDA data

Lac-Mac

Primary DI
00627755521002
Brand
Lac-Mac
Company
Lac-Mac Limited
Model
005XFAH-S
Catalog number
005XFAH-S
Device description
Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size S
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061491000LAC-MAC INNERBLOC O.R. GOWNLac Mac, Ltd.2006-08-09FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627755521002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627755521002006277555210026277555210020627755521002

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, reusableA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a reusable garment intended to be laundered after each use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5194322616shelley.petrovskis@lac-mac.com

Regulatory Flags#

DUNS number
201276334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627755841179Lac-Mac Limited084E-JK084E-JK2024-11-11
00627755531162Lac-Mac005DSBK-M005DSBK-M2024-08-22
00627755541161Lac-Mac005DSBK-L005DSBK-L2024-08-22
00627755551160Lac-Mac005DSBK-XL005DSBK-XL2024-08-22
00627755561169Lac-Mac005DSBK-2XL005DSBK-2XL2024-08-22
00627755571168Lac-Mac005DSBK-3XL005DSBK-3XL2024-08-22
00627755531148Lac-Mac005XXBN-M2024-08-21
00627755531155Lac-Mac005XXCE-M005XXCE-M2024-08-21
00627755541147Lac-Mac005XXBN-L005XXBN-L2024-08-21
00627755541154Lac-Mac005XXCE-L005XXCE-L2024-08-21
00627755551146Lac-Mac005XXBN-XL005XXBN-XL2024-08-21
00627755551153Lac-Mac005XXCE-XL005XXCE-XL2024-08-21
00627755561145Lac-Mac005XXBN-2XL005XXBN-2XL2024-08-21
00627755561152Lac-Mac005XXCE-2XL005XXCE-2XL2024-08-21
00627755571144Lac-Mac005XXBN-3XL005XXBN-3XL2024-08-21
00627755571151Lac-Mac005XXCE-3XL005XXCE-3XL2024-08-21
00627755581143Lac-Mac005XXBN-4XL005XXBN-4XL2024-08-21
00627755581150Lac-Mac005XXCE-4XL005XXCE-4XL2024-08-21
00627755831132Lac-Mac83MH83MH2024-07-03
00627755531124Lac-Mac005XFAQ-M005XFAQ-M2024-01-12

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