FDA.reportPublic FDA data

AMERICAN PROTECTIVE PRODUCTS

Primary DI
10850063938249
Brand
AMERICAN PROTECTIVE PRODUCTS
Company
American Protective Products LLC
Model
G-N506-BL-2X
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
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
10850063938249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085006393824910850063938249

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15