FDA.reportPublic FDA data

AMERICAN PROTECTIVE PRODUCTS

Primary DI
10850063932612
Brand
AMERICAN PROTECTIVE PRODUCTS
Company
American Protective Products LLC
Model
G-N506-BL-2X-M
Published
2025-05-30
Public version status
Update
Distribution status
Not 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
K152720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152720000Xingda Nitrile Powder Free Patient Examination Gloves, Blue ColorXingda Medical Products Co., Ltd.2016-03-10LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850063932612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085006393261210850063932612

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

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
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
10850063938089AMERICAN PROTECTIVE PRODUCTSG-N402-BK-SM2024-06-30
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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