(70 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color
The provided text contains information about the FDA's clearance of Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color. However, it does not contain the detailed acceptance criteria or the specifics of a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter, which affirms substantial equivalence to a predicate device, but does not typically include the full technical study report.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be extracted, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This information is not present in the FDA clearance letter. Such details would typically be found in the manufacturer's submission or a detailed test report. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This information is not present.
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)
- Cannot be provided. This information is not present. The device is a glove, so "ground truth" and "experts" in the context of diagnostic performance are not applicable here. Performance criteria for gloves usually relate to physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from pinholes).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This information is not relevant or present.
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
- Cannot be provided. This type of study (MRMC, AI assistance) is not applicable to an examination glove.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is not applicable to a physical examination glove.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground truth for examination gloves typically involves objective physical and chemical testing against recognized standards (e.g., ASTM standards for medical gloves) for properties like dimensions, tensile strength, elongation, and barrier integrity (e.g., AQL for pinholes).
- Cannot be provided in detail from this document. The document does not specify the ground truth methods used in the testing for the glove, only that it met requirements for substantial equivalence.
8. The sample size for the training set
- Cannot be provided. Not applicable in the context of substantial equivalence for a physical device like a glove, which doesn't typically involve "training sets" in the AI/ML sense.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable.
Summary of available information from the document:
- Trade/Device Name: Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color
- Regulation Number: 880.6250
- Regulation Name: Patient Examination Gloves
- Regulatory Class: I (indicating lower risk and general controls apply)
- Product Code: LZA
- K Number: K030245
- Applicant: PT. ARISTA LATINO Industrial Limited, LTD.
- Indications For Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
- Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.
To obtain the specific acceptance criteria and detailed study data (e.g., AQL levels for pinholes, tensile strength values, elongation at break), one would typically need to review the full 510(k) submission available through FDA's public access, or contact the manufacturer directly, as this information is not typically included in the clearance letter itself.
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APR o 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms.Linga Sumarta Arista Latino Industrial Limited, LTD, P.T. 128 Jalan Kyai Haji Muhammad Mansyur. Jakarta Barat, INDONESIA 11210
Re: K030245
Trade/Device Name: Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: March 21, 2003 Received: March 25, 2003
Dear Ms. Sumarta:
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 mav, 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. Sumarta
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 (OS) 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 yours,
Susan Runge
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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TINDO INDUSTRIAL LTD
Image /page/2/Picture/1 description: The image is a black and white logo. The logo is a circle with a white triangle inside. The triangle is pointing upwards and has a horizontal line through the middle. The logo is simple and modern.
OFFICE : JL. K.H. MOH. MANSYUR 128 JAKARTA 11210 - INDONESIA MAILING ADDRESS : P.O. BOX 4129 JKT 11041 - INDOYESIA TELEPHONE : (021) 639-1907 (4 LINES) FAX : (62-21) 669-0428, 874-0979 TELEX : 42004 NIKKO IA
Section No. 3.
ATTACHMENT #2
INDICATIONS FOR USE STATEMENT
| Applicant: | PT. ARISTA LATINDO IND. LTD. |
|---|---|
| 510(k) Number (if known): | K030245 |
| Device Name: | Nitrile Examination Gloves, Powder Free, Polymer Coated (PURPLE) |
| Indications For Use: |
A patient examination glove is a disposable device intended for medical purpose 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______________________________________________________________________________________________________________________________________________________________
Quts-Lin
(Optimal Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K030245
§ 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.