FDA.reportPublic FDA data

AMERICAN PROTECTIVE PRODUCTS

Primary DI
10850063938089
Brand
AMERICAN PROTECTIVE PRODUCTS
Company
American Protective Products LLC
Model
G-N402-BK-SM
Published
2024-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182528000Nitrile Glove Powder Free BlackHaining Medical Products Co., Ltd.2018-11-15LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850063938089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085006393808910850063938089

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117079262
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850063932568AMERICAN PROTECTIVE PRODUCTSG-N501-BL-XS-M2025-06-20
10850063932575AMERICAN PROTECTIVE PRODUCTSG-N502-BL-SM-M2025-06-20
10850063932582AMERICAN PROTECTIVE PRODUCTSG-N503-BL-MD-M2025-06-20
10850063932599AMERICAN PROTECTIVE PRODUCTSG-N504-BL-LG-M2025-06-20
10850063932605AMERICAN PROTECTIVE PRODUCTSG-N505-BL-XL-M2025-06-20
10850063932612AMERICAN PROTECTIVE PRODUCTSG-N506-BL-2X-M2025-05-30
10850063938010AMERICAN PROTECTIVE PRODUCTSG-N301-VI-XS2024-06-30
10850063938027AMERICAN PROTECTIVE PRODUCTSG-N302-VI-SM2024-06-30
10850063938034AMERICAN PROTECTIVE PRODUCTSG-N303-VI-MD2024-06-30
10850063938041AMERICAN PROTECTIVE PRODUCTSG-N304-VI-LG2024-06-30
10850063938058AMERICAN PROTECTIVE PRODUCTSG-N305-VI-XL2024-06-30
10850063938065AMERICAN PROTECTIVE PRODUCTSG-N306-VI-2X2024-06-30
10850063938072AMERICAN PROTECTIVE PRODUCTSG-N401-BK-XS2024-06-30
10850063938096AMERICAN PROTECTIVE PRODUCTSG-N403-BK-MD2024-06-30
10850063938102AMERICAN PROTECTIVE PRODUCTSG-N404-BK-LG2024-06-30
10850063938119AMERICAN PROTECTIVE PRODUCTSG-N405-BK-XL2024-06-30
10850063938126AMERICAN PROTECTIVE PRODUCTSG-N406-BK-2X2024-06-30
10850063938133AMERICAN PROTECTIVE PRODUCTSG-N601-BK-XS2024-06-30
10850063938140AMERICAN PROTECTIVE PRODUCTSG-N602-BK-SM2024-06-30
10850063938157AMERICAN PROTECTIVE PRODUCTSG-N603-BK-MD2024-06-30

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