(119 days)
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.
MEDISPO and MEDISPO-PF meet the requirements for surgical gloves described by ASTM D3577.
Acceptance Criteria and Device Performance Study for H.B.M. USA Co., Inc. – Latex Sterile Surgical Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Properties | |
| Meets requirements for surgical gloves described by ASTM D3577 | Tests conducted per ASTM D3577 indicate the product meets the requirements. |
| Biocompatibility | |
| No sensitization | Tests indicate no sensitization. |
| No irritation | Tests indicate no irritation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Tests conducted per ASTM D3577." ASTM D3577 itself outlines standard test methods and specifications for rubber surgical gloves, which would implicitly define sample sizes for specific tests (e.g., tensile strength, elongation, barrier integrity).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For medical devices like surgical gloves, "ground truth" is typically established through adherence to recognized international standards (like ASTM D3577), which specify objective laboratory testing methods rather than requiring expert consensus on subjective observations.
4. Adjudication Method for the Test Set
Not applicable. The evaluation of surgical gloves against ASTM D3577 involves objective laboratory measurements and tests, not subjective interpretations requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for diagnostic imaging or screening devices where human readers interpret complex data. Surgical gloves are evaluated based on their physical and biocompatibility properties, not on reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable. Surgical gloves are not an AI-driven device or an algorithm. Their performance is assessed through physical and chemical testing.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to the specifications and test methods outlined in the ASTM D3577 standard. This includes objective measurements of properties like dimensions, physical integrity (e.g., absence of holes), tensile strength, and elongation, as well as biocompatibility tests for irritation and sensitization.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, this question is not relevant.
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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 requirementsfor surgical gloves described by ASTM D3577. |
| APPLICANT | H.B.M. USA Co., Inc.HBM Building98-02 218 StreetQueens Village, NY 11429Contact PersonGordon X. Hu, President(718)776-6666 Ph.(718)776-4666 Fax |
| PREDICATE DEVICE | This product is already approved and for sale in theEuropean Union and refers to various surgeon'sgloves already on the market in the US as predicatedevices including: POWDERED LATEX SURGEON'SGLOVES by CEPHAS MEDICAL and MAXTERSTERILE POWDER FREE SURGICAL GLOVES. |
| INDICATIONS FOR USE | MEDISPO powdered surgeon's gloves are steriledisposable devices made of natural rubber latex thatbears powder to facilitate donning, and it is intendedto be worn on the hands, usually in surgical settings,to provide a barrier against potentially infectiousmaterials and other contaminants.MEDISO-PF powder-free surgeon's gloves are steriledisposable devices made of natural rubber latex thatmay bear a trace amount of glove powder and isintended to be worn on the hands, usually in surgicalsettings, to provide a barrier against potentiallyinfectious materials and other contaminants. |
| TESTING | Tests conducted per ASTM D3577, indicate that theproduct meets the requirements. Tests also indicateno sensitization or irritation. |
| CONCLUSION | It can be concluded that MEDISPO and MEDISPO-PF surgical gloves will perform according to theperformance standards referenced and thereforemeet ASTM standards, FDA requirements andlabeling claims. This device is substantiallyequivalent to currently marketed devices. |
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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.
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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
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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)
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§ 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).