(24 days)
A 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.
POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ. A 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.
The provided text describes the regulatory clearance for "POWDERED VINYL EXAM GLOVES, WHITE" (K030927) and references its substantial equivalence to another device (K021961). The acceptance criteria for medical gloves are typically defined by recognized standards such as ASTM. The document states that the device met or exceeded specific ASTM standards and other tests.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards/Tests) | Reported Device Performance |
|---|---|
| ASTM D 5250-00E4 | Met or exceeded |
| ASTM D 5151-99 | Met or exceeded |
| ASTM D 6124-01 | Met or exceeded |
| ISO 2859 | Met or exceeded |
| MIL Std 105E | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
| Bio-Burden (Procedure Method 8315) | Met or exceeded |
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 does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). This information is typically detailed in the full test reports, which are not included here.
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)
This information is not provided in the document. Testing for medical gloves (physical properties, biocompatibility) typically involves laboratory testing against established standards, not necessarily relying on expert "ground truth" panels in the same way an AI diagnostic tool might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of device and testing described. The performance is assessed against standardized objective measurements defined by ASTM, ISO, and MIL standards, not subjective adjudication.
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
No such study was conducted or mentioned. This type of study is relevant for AI-powered diagnostic tools where human interpretation is assisted by AI, which is not the case for examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable for an examination glove. There is no algorithm or AI component in this device. The device itself (the glove) is the standalone entity being evaluated for its physical and biocompatibility properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for examination gloves is defined by the objective, measurable performance requirements specified in the referenced ASTM, ISO, and MIL standards for physical properties (e.g., tensile strength, elongation, barrier integrity) and validated laboratory tests for biocompatibility (dermal sensitization, primary skin irritation, bioburden).
8. The sample size for the training set
This is not applicable as this device is an examination glove and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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APR 1 7 2003
| KO30927 | |
|---|---|
| 510(k) SUMMARY | |
| Submitted For: | COPIOUMED INTERNATIONAL, INC. |
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for COPIOUMEDJANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550Phone:775-342-2612Fax:775-342-2613E-Mail:Tuckerjan@aol.com |
| Date of Submission: | 19 March 2003 |
| Device Name: | POWDERED VINYL EXAM GLOVES,WHITEClass I Device, 80LYZ |
| Proprietary Name: | (Multiple Private Labels) |
| Labels/Labeling: | This device will be marketed to healthcare professionals atDentist and Doctor Offices, Laboratories, Clinics andHospitals through its distributors for the intended use. |
| Intended Use: | A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's handor finger to prevent contamination between patient andexaminer. |
| Substantial Equivalence: | Both in its intended use and/or physicalcharacteristics, this device is equivalent to devicescurrently marketed by U.S. companies. Except for U.S.P.powder, it is the exact same glove manufactured inapproved 510(k) K021961. |
EXHIBIT K
Page 49 of 50
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510k) Summary page 2.
HO30927
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests:
ASTM D 5250-00E4 ASTM D 5151-99 ASTM D 6124-01 ISO 2859 MIL Std 105E Bio-Compatibility: Dermal Sensitization Primary Skin Irritation Bio-Burden (Procedure Method 8315)
Conclusion: Except for the U.S.P. powder, this device is the same glove as approved in K021961.
EXHIBIT K
Page 50 of 50
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.
APR 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
COPIOUMED International, Incorporated C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550
Re: K030927
Trade/Device Name: Powdered Vinyl Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 19, 2003 Received: March 24, 2003
Dear Ms. Tucker:
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.
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Page 2 - Ms. Tucker
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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runres
Susan Runner, DDS, MA Interim 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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INDICATIONS FOR USE
COPIOUMED INTERNATIONAL, INC. APPLICANT:
510(k) NUMBER: - Ko30927
POWDERED VINYL EXAM GLOVES, DEVICE NAME: WHITE
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_$\checkmark$
(Optional Format 1-2-96)
Olen Slim
sthesiology, General Hospital
510(k) Number: K030927
EXHIBIT B
Page 2 of 50
§ 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.