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Found 6 results
510(k) Data Aggregation
K Number
K091097Device Name
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
Manufacturer
PROMEDICAL PRODUCTS CO., LTD.
Date Cleared
2009-05-27
(41 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PROMEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K080629Device Name
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
Manufacturer
PROMEDICAL PRODUCTS CO., LTD.
Date Cleared
2008-10-20
(229 days)
Product Code
KKX, MMP
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
PROMEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
Device Description
Not Found
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K Number
K080627Device Name
PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
Manufacturer
PROMEDICAL PRODUCTS CO., LTD.
Date Cleared
2008-04-24
(50 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PROMEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
proMedical Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of micro-organisms, body fluids, and particulate matter.
Device Description
proMedical Surgical Gowns are disposable, single use, sterile surgical gowns manufactured from non-woven spunbond-meltblown-spunbond polypropylene or spun-laced fabrics. Gowns are provided as listed below.
| No. | Model<br>Number | Name | Size | Category |
|-----|-----------------|---------------------------------------------|-------------------------------------|------------|
| 1 | 18-001 | OR Spunlace Gown, Standard | Medium, Large, X-large,<br>XX-Large | Standard |
| 2 | 18-101 | OR Spunlace Gown, with Fabric Reinforcement | Medium, Large, X-large,<br>XX-Large | Reinforced |
| 3 | 18-201 | OR Spunlace Gown, with Poly Reinforcement | Medium, Large, X-large,<br>XX-Large | Reinforced |
| 4 | 18-301 | OR SMS Gown, Standard | Medium, Large, X-large,<br>XX-Large | Standard |
| 5 | 18-401 | OR SMS Gown, with Fabric Reinforcement | Medium, Large, X-large,<br>XX-Large | Reinforced |
| 6 | 18-501 | OR SMS Gown, with Poly Reinforcement | Medium, Large, X-large,<br>XX-Large | Reinforced |
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K Number
K042111Device Name
PROMEDICAL SURGICAL GOWNS
Manufacturer
PROMEDICAL PRODUCTS CO., LTD.
Date Cleared
2004-12-10
(127 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PROMEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
proMedical Products Co. LTD intends to market Non-sterile surgical gowns identified in 21 CFR 878.4040 as medical devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from the transfer of microorganisms, bodily fluids and particulate material.
Device Description
Surgical Gowns
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K Number
K042131Device Name
PROMEDICAL SURGICAL DRAPES
Manufacturer
PROMEDICAL PRODUCTS CO., LTD.
Date Cleared
2004-12-10
(123 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
PROMEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
proMedical Products Co. LTD intends to market Non-sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination
Device Description
Non-sterile Disposable Surgical Drapes made of natural or synthetic material.
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K Number
K042137Device Name
PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
Manufacturer
PROMEDICAL PRODUCTS CO., LTD.
Date Cleared
2004-10-05
(57 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
PROMEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
proMedical Products Co. Ltd. intends to market Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.
Device Description
Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.
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