(85 days)
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.
Powder-Free Vinyl Examination Glove
The provided document, Premarket Notification 510(k) K071022 for a Powder-Free Vinyl Examination Glove, does not contain any information regarding AI/ML device performance or studies involving human readers, training sets, or ground truth as typically associated with AI-powered medical devices.
Instead, this submission is for a medical glove, and the acceptance criteria and supporting studies are based on traditional physical and biocompatibility testing according to established ASTM and ISO standards.
Therefore, many of the requested categories in your prompt are not applicable to this type of medical device submission. I will answer the applicable questions based on the provided text, and explicitly state when a category is not relevant.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250-00 | Meets ASTM D 5250-00 (implied, no specific values listed for device) |
| Width (Small) | 85 +/- 5 mm | (Implicitly meets, specific value not reported for device) |
| Width (Medium) | 95 +/- 5 mm | (Implicitly meets, specific value not reported for device) |
| Width (Large) | 105 +/- 5 mm | (Implicitly meets, specific value not reported for device) |
| Width (X-Large) | 115 +/- 5 mm | (Implicitly meets, specific value not reported for device) |
| Length (all sizes) | 250 +/- 10 mm | (Implicitly meets, specific value not reported for device) |
| Thickness (Finger) | 0.05 mm minimum | (Implicitly meets, specific value not reported for device) |
| Thickness (Palm) | 0.1 mm minimum | (Implicitly meets, specific value not reported for device) |
| Physical Properties | Meets ASTM D 5250-00 | Meets ASTM D 5250-00 (implied, no specific values listed for device) |
| Tensile Strength (Before Aging) | 9 MPa minimum | 9 MPa minimum (stated specification) |
| Tensile Strength (After Aging) | 9 MPa minimum | 9 MPa minimum (stated specification) |
| Ultimate Elongation | 300% minimum | 300% minimum (stated specification) |
| Freedom from pinholes | Meets ASTM D 5250-00 and ASTM D 5151-99 | Meets ASTM D 5250-00 and ASTM D 5151-99 (implied) |
| Water Leak Test | AQL 2.5, Level I | AQL 2.5, Level I (stated specification) |
| Powder Free | Meets ASTM D 6124-00 and ASTM D 5250-00 | Meets ASTM D 6124-00 and ASTM D 5250-00 (implied) |
| Biocompatibility | Based on ISO 10993 | |
| Cytotoxicity - Agar Diffusion | (Acceptance criteria implied by standard) | Passed |
| Primary Skin Irritation | (Acceptance criteria implied by standard) | Passed |
| Guinea Pig Sensitization | (Acceptance criteria implied by standard) | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "The performance test data that support a determination of substantial equivalence are described above in Section 7" (which is the section outlining standards and specifications). However, it does not explicitly state the sample sizes used for the physical or biocompatibility testing, nor does it specify the data provenance (country of origin, retrospective/prospective). The testing would typically be prospective, conducted by the manufacturer (Glormed Colombia S.A.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a physical product (medical glove). Ground truth in the context of expert review (e.g., for image interpretation) is not relevant here. Performance is measured against physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See explanation for #3. Adjudication methods like 2+1 or 3+1 are used for expert disagreement in diagnostic tasks, which is not relevant for glove testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical glove, not an AI software. No MRMC study or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by conformance to internationally recognized industry standards such as ASTM D 5250-00, ASTM D 5151-99, ASTM D 6124-00, and ISO 10993. These standards define the acceptable physical properties, non-toxicity, and integrity of medical examination gloves. There is no biological "ground truth" from patients or pathology in the sense of AI diagnostics.
8. The sample size for the training set
Not applicable. This device is a medical glove and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See explanation for #8.
{0}------------------------------------------------
Premarket Notification 510(k) K071022
Powder-Free Vinyl Examination Glove
21.0 Summary
- [1] 510(k) Summary of Safety and Effectiveness Information
- (2) Submitter: Glormed Colombia S.A. Mamonal Km. 9 Zona Franca La Candelaria, Manzana L Cartagena, Colombia Telephone: +57-5-668-6650 Fax: +57-5-668-6651
- Contact: Sam Kao Telephone No. +1-(714) 953-5326 FAX No. +1-(714) 953-5550 E-mail: sam(@)kalmedsupply.com
June 14, 2007 Date:
- Trade name: (31 (Multiple private labels) Common name: Powder-Free Examination Glove, Vinyl Classification name: Patient examination gloves, powder-free (per proposed 21 CFR §880.6251)
- The predicate device is a Class I, powder-free vinyl exam glove 80LYZ that meets [4] all of the requirements of ASTM D 5250-00, "Standard Specification for Poly(vinvl chloride) Gloves for Medical Application."
- [5] The powder-free vinyl exam glove meets the current specifications of ASTM D 5250-00, "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. "
- A patient examination glove is a medical device intended for medical purposes that (61 is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.
- [7] Applicant's device comparison with FDA required technological characteristics:
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 5250-00 |
| Physical Properties | Meets ASTM D 5250-00 |
| Freedom from pinholes | Meets ASTM D 5250-00 and ASTM D 5151-99 |
| Powder Free | Meets ASTM D 6124-00 and ASTM D 5250-00 |
{1}------------------------------------------------
Premarket Notification 510(k) K071022
Powder-Free Vinyl Examination Glove
| Biocompatibilty: (based on ISO 10993) | |
|---|---|
| Cytotoxicity - Agar Diffusion | Passed |
| Primary Skin Irritation | Passed |
| Guinea Pig Sensitization | Passed |
Measured Parameter of Applicant Device Compared to Standard:
| ASTM D5250 / ASTM D 6124 Requirement | Applicant Device Specification |
|---|---|
| Width (mm) | |
| Small | 85 +/- 5 |
| Medium | 95 +/- 5 |
| Large | 105 +/- 5 |
| X-Large | 115 +/- 5 |
| Length (mm) – all sizes | 250 +/- 10 |
| Thickness (mm) -- all sizes | |
| Finger | 0.05 minimum |
| Palm | 0.1 minimum |
| Physical Testing | |
| Tensile Strength | |
| (in MPa) | Before Aging 9 minAfter Aging 9 min |
| Ultimate Elongation | |
| (in %) | 300% min |
| Water Leak Test | AQL 2.5, Level I |
Both its intended use and physical characteristics is equivalent to legally marketed vinyl powder-free examination gloves. It is substantially equivalent to gloves approved as Glormed International's vinyl powder-free glove K983494.
- The performance test data that support a determination of substantial equivalence [8] are described above in Section 7.
- 191 Clinical data are not needed for examination gloves.
- [10] (Multiple private labels) Powder-Free Vinyl Examination Glove is safe and effective and will perform according to glove performance standards referenced in Section 7 above, thereby meeting ASTM D5250 and D6124 standards, FDA requirements, pinhole AQL requirement, and labeling claims for the product. Consequently, this patient examination glove is substantially equivalent to currently marketed patient examination gloves.
- [11] This summary will include any additional safety and effectiveness information reasonably deemed necessary by FDA.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol, with three wing-like shapes stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2007
Glormed Colombia S.A. C/O Mr. Sam Kao Project Manager KalMed Supply 2700 North Main Street Suite 506 Santa Ana, California 92705
Re: K071022
Trade/Device Name: Vinyl Patient Examination Glove, Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 14, 2007 Received: June 15, 2007
Dear Mr. Kao:
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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 -- Mr. Kao
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suste Y. Michie and
Chris Lins, 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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K071022
Device Name: Vinyl Patient Examination Glove, Powder-Free
Indications For Use:
Based upon 21 CFR §880.6251 "Patient examination glove, powder-free"
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.
Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule M. Muephy, 42
(Division Sign-Off) Oivision of Anesthesiology, General Hospital infection Control, Dental Devices
Page 1 of _
510(k) Number: K070227
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.