(119 days)
Not Found
POWDERED LATEX SURGEON'S GLOVES by CEPHAS MEDICAL, MAXTER STERILE POWDER FREE SURGICAL GLOVES
No
The device description and intended use clearly define the product as surgical gloves, with no mention of AI or ML technology. The performance studies are based on standard ASTM testing for gloves.
No.
The device acts as a barrier to prevent contamination, which is a protective function, not a therapeutic one for treating or alleviating a condition.
No
The document describes surgical gloves, which are barrier devices, not diagnostic tools. They are used to prevent the transmission of infectious materials rather than to identify or diagnose medical conditions.
No
The device is a physical product (surgical gloves) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are "intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier device used for protection during medical procedures.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The gloves do not perform any such tests.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the MEDISPO and MEDISPO-PF surgeon's gloves are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
MEDISPO powdered surgeon's gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
MEDISO-PF powder-free surgeon's gloves are sterile disposable devices made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Product codes
KGO
Device Description
MEDISPO and MEDISPO-PF meet the requirements for surgical gloves described by ASTM D3577.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests conducted per ASTM D3577, indicate that the product meets the requirements. Tests also indicate no sensitization or irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
POWDERED LATEX SURGEON'S GLOVES by CEPHAS MEDICAL, MAXTER STERILE POWDER FREE SURGICAL GLOVES
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).
0
H.B.M. USA Co., Inc. – Abbreviated 510k application for Latex Sterile Surgical Gloves
MAY 1 1 2005
KOSOOTI
510(k) Summary/Statement Requirement
| DEVICE NAME | Powdered and Powder-Free Latex Surgical Gloves |
|---|---|
| CLASSIFICATION | Class I, 21CFR878.4460 |
| TRADE NAME | MEDISPO and MEDISPO-PF |
| DEVICE DESCRIPTION | MEDISPO and MEDISPO-PF meet the requirements |
| for surgical gloves described by ASTM D3577. | |
| APPLICANT | H.B.M. USA Co., Inc. |
| HBM Building | |
| 98-02 218 Street | |
| Queens Village, NY 11429 |
Contact Person
Gordon X. Hu, President
(718)776-6666 Ph.
(718)776-4666 Fax |
| PREDICATE DEVICE | This product is already approved and for sale in the
European Union and refers to various surgeon's
gloves already on the market in the US as predicate
devices including: POWDERED LATEX SURGEON'S
GLOVES by CEPHAS MEDICAL and MAXTER
STERILE POWDER FREE SURGICAL GLOVES. |
| INDICATIONS FOR USE | MEDISPO powdered surgeon's gloves are sterile
disposable devices made of natural rubber latex that
bears powder to facilitate donning, and it is intended
to be worn on the hands, usually in surgical settings,
to provide a barrier against potentially infectious
materials and other contaminants.
MEDISO-PF powder-free surgeon's gloves are sterile
disposable devices made of natural rubber latex that
may bear a trace amount of glove powder and is
intended to be worn on the hands, usually in surgical
settings, to provide a barrier against potentially
infectious materials and other contaminants. |
| TESTING | Tests conducted per ASTM D3577, indicate that the
product meets the requirements. Tests also indicate
no sensitization or irritation. |
| CONCLUSION | It can be concluded that MEDISPO and MEDISPO-
PF surgical gloves will perform according to the
performance standards referenced and therefore
meet ASTM standards, FDA requirements and
labeling claims. This device is substantially
equivalent to currently marketed devices. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.
MAY 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gordon X. Hu President H.B.M. USA Company, Incorporated HBM Building, 98-02, 218 Street Queens Village, New York 11429
Re: K050071
Trade/Device Name: MEDISPO Powdered Surgeon's Gloves and MEDISPO-PF Powder-free Surgeon's Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 14, 2005 Received: April 19, 2005
Dear. Mr. Hu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinona, of to arrand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 MA), it may of subject to back and frederal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Hu
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of act FDA has made a determination that your device complies with other requirements mount that I Drima many Federal statutes and regulations administered by other Federal agencies. or the For or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and home (21 er er read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in J . The FDA finding of substantial equivalence of your device to a premails and the redicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you dontact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj overnit Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
H.B.M. USA Co., Inc. - Abbreviated 510k application for Latex Sterile Surgical Gloves Amended on 04.12.05
Indications for Use Statement 3.0
Indications for Use
510(k) Number (if known): K050071
Device Name: MEDISPO powdered surgeon's gloves and MEDISPO-PF powder-free surgeon's gloves
Indications For Use:
MEDISPO powdered surgeon's gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
MEDISPO-PF powder-free surgeon's gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to he worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use (21 CFR 801 Subpart C)
a se se se to the result to contrast and
. 1988
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela A. Murphy, KO
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Intection Control, Dental Devices
3 ID('k) Number _
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