FDA.reportPublic FDA data

Black Python

Primary DI
00811114030605
Brand
Black Python
Company
Unisafe Inc.
Model
PY700S
Device description
Powder-Free Nitrile Examination Gloves
Published
2023-07-31
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811114030650PackageGS110In Commercial Distribution
00811114030605PrimaryGS10
10811114030602Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811114030650008111140306508111140306500811114030650
00811114030605008111140306058111140306050811114030605
1081111403060210811114030602

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
080171627
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811114031602ProglovePGV500M2026-05-21
00811114031596ProglovePGV500S2026-05-20
00811114031619ProglovePGV500L2026-05-20
00811114031626ProglovePGV500XL2026-05-20
00811114031930MilgloveN5SM2025-04-11
00811114031947MilgloveN5MD2025-04-11
00811114031954MilGloveN5LG2025-04-11
00811114031961MilgloveN5XL2025-04-11
00811114031978MilgloveN5XXL2025-04-11
00811114031985MilgloveN5SM2025-04-11
00811114032029MilgloveN5MD2025-04-11
00811114031992MilGloveN5LG2025-04-11
00811114032005MilgloveN5XL2025-04-11
00811114032012MilgloveN5XXL2025-04-11
00811114030612Black PythonPY700M2023-07-31
00811114030629Black PythonPY700L2023-07-31
00811114030636Black PythonPY700XL2023-07-31
00811114030704CopperheadCH500S2023-07-31
00811114030735CopperheadCH500L2023-07-31
00811114030742CopperheadCH500XL2023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641309Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641316Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641323Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641330Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641347Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00366975065506Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22