FDA.reportPublic FDA data

BLOSSOM

Primary DI
10723860494853
Brand
BLOSSOM
Company
Mexpo International Inc.
Model
BM 49485-N-PF
Catalog number
BM 49485-N-PF
Device description
NITRILE EXAMINATION GLOVES POWDER FREE AVOCADO GREEN (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

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
00723860494856PrimaryGS10
10723860494853Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00723860494856007238604948567238604948560723860494856
1072386049485310723860494853

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.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00723860973252BLOSSOMBM 97325-CHL-LG-PFBM 97325-CHL-LG-PF2022-02-23
00723860973269BLOSSOMBM 97326-CHL-LG-PFBM 97326-CHL-LG-PF2022-02-23
00723860973276BLOSSOMBM 97327-CHL-LG-PFBM 97327-CHL-LG-PF2022-02-23
00723860973283BLOSSOMBM 97328-CHL-LG-PFBM 97328-CHL-LG-PF2022-02-23
00723860973290BLOSSOMBM 97329-CHL-LG-PFBM 97329-CHL-LG-PF2022-02-23
00723860977151BLOSSOMBM 97715-CHL-P-PFBM 97715-CHL-P-PF2022-02-23
00723860977168BLOSSOMBM 97716-CHL-P-PFBM 97716-CHL-P-PF2022-02-23
00723860977175BLOSSOMBM 97717-CHL-P-PFBM 97717-CHL-P-PF2022-02-23
00723860977182BLOSSOMBM 97718-CHL-P-PFBM 97718-CHL-P-PF2022-02-23
00723860977199BLOSSOMBM 97719-CHL-P-PFBM 97719-CHL-P-PF2022-02-23
00723860013323BLOSSOMBM 1355-RD DAMBM 1355-RD DAM2023-06-16
00723860013347BLOSSOMBM 1366-RD DAMBM 1366-RD DAM2023-06-16
00723860013668BLOSSOMBM1366B-RD DAMBM1366B-RD DAM2023-06-16
00723860014559BLOSSOMBM1355B-RD DAMBM1355B-RD DAM2023-06-16
00723860015556BLOSSOMBM 1555-RD DAM BLKBM 1555-RD DAM BLK2023-06-16
00723860015662BLOSSOMBM 1566-RD DAM BLKBM 1566-RD DAM BLK2023-06-16
00723860016553BLOSSOMBM1655-RD DAMBM1655-RD DAM2023-06-16
00723860016669BLOSSOMBM 1666-RD DAMBM 1666-RD DAM2023-06-16
10723860013320BLOSSOMBM 1355-RD DAMBM 1355-RD DAM2023-06-16
10723860013344BLOSSOMBM 1366-RD DAMBM 1366-RD DAM2023-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09551006060525NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060532NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060549NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060556NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060563NITRILECARE PREMIUMCAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060624NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060631NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060648NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060655NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060662NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060822NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061225NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061249CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08