FDA.report

BLOSSOM

Primary DI
10723860062298
Brand
BLOSSOM
Company
Mexpo International Inc.
Model
BM 6229-LTX PF
Catalog number
BM 6229-LTX PF
Device description
LATEX EXAMINATION GLOVES TEXTURED POWDER FREE (X-LARGE)
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
LYYLatex Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723860062291PrimaryGS10
10723860062298Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723860062291007238600622917238600622910723860062291
1072386006229810723860062298

GMDN Terms

TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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
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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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