(71 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.
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES, Class I Device, 80LZA
The provided document is a 510(k) summary for Powder-Free Lavender/Purple Nitrile Exam Gloves. It details the device's characteristics and its equivalence to previously marketed devices. However, it does not describe specific acceptance criteria in the typical sense of a detailed performance study with defined thresholds for sensitivity, specificity, accuracy, etc., which would be expected for a diagnostic or AI-driven device.
Instead, the "acceptance criteria" for this device are framed as compliance with recognized ASTM standards and biocompatibility tests, which are pass/fail criteria for material properties and safety. The "study" proving the device meets these criteria is the performance of these tests, demonstrating compliance.
Here's the breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 3578-00 | Met or exceeded |
| ASTM D 5712-00 | Met or exceeded |
| ASTM D 6124-00 | Met or exceeded |
| ASTM D 5151-00 | Met or exceeded |
| ASTM F 1671 | Met or exceeded |
| ASTM F 1383 | Met or exceeded |
| ASTM F 903 | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | 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 specify the sample sizes used for each ASTM test or biocompatibility test. It also does not explicitly state the country of origin of the data for these tests or if they were retrospective or prospective. It can be inferred that these tests were conducted on samples of the manufactured gloves by the applicant (SHEEN MORE ENTERPRISE CO., LTD. in Taiwan R.O.C.) or a testing facility contracted by them.
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 is not applicable to the evaluation of examination gloves. The "ground truth" for these types of devices is established through adherence to standardized laboratory test methods (e.g., tensile strength, tear resistance, barrier integrity, biocompatibility), not through expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The evaluation of these gloves against ASTM standards and biocompatibility involves objective laboratory measurements and standardized protocols, not human adjudication of subjective interpretations.
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
This is not applicable as the device is a medical glove, not an AI-assisted diagnostic tool or a device requiring human reader interpretation in its primary function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product (medical glove) and does not involve any algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on the standards and specifications outlined in the ASTM test methods and biocompatibility guidelines. These standards define the acceptable physical properties (e.g., tensile strength, elongation, puncture resistance) and biological responses (e.g., lack of irritation or sensitization) for patient examination gloves.
8. The sample size for the training set
This is not applicable as the device is a physical product and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical product and does not involve an algorithm or a training set.
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FEB 1 3 2002
510(k) SUMMARY
| Submitted For: | SHEEN MORE ENTERPRISE CO., LTD.No. 16 Tou Kung Six RoadTou-Liu Expanded Industrial ParkTou-Liu City, Yun-Lin CountyTaiwan R.O.C. |
|---|---|
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for SHEEN MORE ENTERPRISECO., LTD.JANNA 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: | 29 November 2001 |
| Device Name: | POWDER-FREE LAVENDER/PURPLE NITRILEEXAM GLOVES, Class I Device, 80LZA |
| Proprietary Name: | (Multiple Labels) Powder-Free Lavender/Purple NitrileExam Gloves. |
| 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 color, itis substantially Equivalent to the device manufactured bySinochem Ningbo Latex Glove Factory's K980802 gloveand Ningbo Yujiang's Lavender/Purple Nitrile Glove(K003563). |
EXHIBIT M
Page 48 of 49
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510k) Summary page 2.
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests:
ASTM D 3578-00 ASTM D 5712-00 ASTM D 6124-00 ASTM D 5151-00 ASTM F 1671 ASTM F 1383 ASTM F 903 Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices Approved as K980802 and K003563.
EXHIBIT M
page 49 of 49
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized birds in flight, stacked on top of each other. The logo is in black and white.
Public Health Service
FEB 1 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sheen More Enterprise Company Limited C/O Janna P. Tucker Consultant Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434-9550
Re: K013998
Ro13770
Trade/Device Name: Powder-Free Lavender/Purple Nitrile Exam Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: November 29, 2001 Received: December 4, 2001
Dear Ms. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases one the device is substantially equivalent (for the itelered above and have economissore) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to may as, as, reclassified in accordance with the provisions of Antendinents, or to devices and have of the Act (Act) that do not require approval of a premarket the redelar Pood, Drug, and Conneasy, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include condons provisions of the stration, 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 IT your device is classinod (200 as of ditional controls. Existing major regulations affecting (I MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be auvrasod that 1 Dr. determination that your device complies with other requirements
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Page 2 - Ms. Tucker
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ouctures and securements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT rat 807), adolity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are quadiation 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 110(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 If you desire pochio as a rart 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and Office of Comphance wee, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under nother for OF CF ICP of the Division of Small Manufacturers, International and the receiner of over 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 yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
APPLICANT:
SHEEN MORE ENTERPRISE CO., LTD.
510(k) NUMBER:
KO1 3998
POWDER-FREE LAVENDER/PURPLE DEVICE NAME: NITRILE EXAM GLOVES
A patient examination glove is a disposable device intended for medical purposes that is I pations chammanen grow of inger 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
(Optional Format 1-2-96)
Chis S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev Fifth Number _
EXHIBIT B
Page 2 of 49
§ 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.