FDA.report

BLOSSOM

Primary DI
10723860423853
Brand
BLOSSOM
Company
Mexpo International Inc.
Model
BM 42385-N-PF
Catalog number
BM 42385-N-PF
Device description
NITRILE EXAMINATION GLOVES POWDER FREE SOFT BLUE (X-SMALL)
Published
2022-02-21
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
true

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723860423856PrimaryGS10
10723860423853Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723860423856007238604238567238604238560723860423856
1072386042385310723860423853

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
779982974
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10723860013320BLOSSOMBM 1355-RD DAMBM 1355-RD DAM2023-06-16
10723860013344BLOSSOMBM 1366-RD DAMBM 1366-RD DAM2023-06-16
10723860013665BLOSSOMBM1366B-RD DAMBM1366B-RD DAM2023-06-16
10723860014556BLOSSOMBM1355B-RD DAMBM1355B-RD DAM2023-06-16
10723860015553BLOSSOMBM 1555-RD DAM BLKBM 1555-RD DAM BLK2023-06-16
10723860015669BLOSSOMBM 1566-RD DAM BLKBM 1566-RD DAM BLK2023-06-16
10723860016550BLOSSOMBM1655-RD DAMBM1655-RD DAM2023-06-16
10723860016666BLOSSOMBM 1666-RD DAMBM 1666-RD DAM2023-06-16
10723860423754BLOSSOMBM 42375-DON-N-PFBM 42375-DON-N-PF2023-06-09
10723860423761BLOSSOMBM 42376-DON-N-PFBM 42376-DON-N-PF2023-06-09
10723860423778BLOSSOMBM 42377-DON-N-PFBM 42377-DON-N-PF2023-06-09
10723860423785BLOSSOMBM 42378-DON-N-PFBM 42378-DON-N-PF2023-06-09
10723860423792BLOSSOMBM 42379-DON-N-PFBM 42379-DON-N-PF2023-06-09
10723860110012BLOSSOMFM-B1001FM-B10012022-03-01
10723860110029BLOSSOMFM-G1002FM-G10022022-03-01
10723860110036BLOSSOMFM-P1003FM-P10032022-03-01
10723860110043BLOSSOMFM-W1004FM-W10042022-03-01
10723860110050BLOSSOMFM-M1005FM-M10052022-03-01
10723860112061BLOSSOMFM-P1206FM-P12062022-03-01
10723860241419THE SEATS FM-B24141TS FM-B241412022-03-01

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