(206 days)
Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Latex Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Length (XS, S, M, L, XL) | 240 mm (min.) | 240 mm (min.) |
| Palm Width (XS) | 75 ± 5 mm | 75 ± 5 mm |
| Palm Width (S) | 80 ± 10 mm | 80 ± 10 mm |
| Palm Width (M) | 95 ± 10 mm | 95 ± 10 mm |
| Palm Width (L) | 105 ± 10 mm | 105 ± 10 mm |
| Palm Width (XL) | 115 ± 5 mm | 115 ± 5 mm |
| Cuff Thickness | 0.10 mm (min.) | 0.10 mm (min.) |
| Palm Thickness | 0.10 mm (min.) | 0.10 mm (min.) |
| Finger Tip Thickness | 0.10 mm (min.) | 0.10 mm (min.) |
| Physical Properties | ||
| Tensile Strength (Before Ageing) | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation (Before Ageing) | 650 % (min.) | 650 % (min.) |
| Tensile Strength (After Ageing at 70°C for 168 hrs) | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation (After Ageing at 70°C for 168 hrs) | 500 % (min.) | 500 % (min.) |
| Performance Requirements | ||
| Sterility | Fails sterility: AQL N/A, Inspection Level A (Implies 0 defects) | Meets the sterility assurance level. |
| Freedom from holes | Holes: AQL 2.5, Inspection Level 1 | Meets FDA pinhole requirement. |
| Dimensions & Thickness | Width Length: AQL 4, Inspection Level S-2 | Device is reported to meet the specified dimensions. |
| Physical Properties after ageing | Before and (after ageing): AQL 4, Inspection Level S-2 | Device is reported to meet the specified physical properties. |
| Powder Free Residue | Exceeds Maximum Limit: AQL N/A, N=5 | Meets labeling claim (implicitly includes residue). |
| Protein Content | Exceeds Recommended Maximum Limit: AQL N/A, N=3 (Labeling Claim: 50 ug or less) | Meets protein content labeling claim (50ug or less). |
| Powder Amount | Exceeds Recommended Maximum Limit: AQL N/A, N=2 | (Implicitly met by labeling claim and ASTM D 3578-01) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a consolidated sample size for a single "test set" in the context of a clinical trial or algorithm evaluation. Instead, it refers to differing sample sizes/inspection levels (e.g., N=5 for Powder Free Residue, N=3 for Protein Content, N=2 for Powder Amount, Inspection Level 1 for holes) for various performance requirements.
The data provenance is presented as internal testing and conformity to standards. The document is from Indonesia, suggesting the testing was likely conducted in Indonesia. The data is retrospective in the sense that the results are presented as already achieved and certified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and study. The "ground truth" for gloves is adherence to specified physical and chemical properties and performance standards (like ASTM D 3578-01). This is determined by laboratory testing against objective criteria, not by expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Laboratory tests against established standards do not typically involve adjudication methods like those used in clinical image interpretation. Results are quantitatively measured and compared against defined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often with AI assistance. For examination gloves, the performance is assessed through laboratory testing of material properties and barrier integrity.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical product (examination gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance is based on:
- Standard Specifications: Specifically, the ASTM D 3578-01 standard for latex examination gloves, which defines dimensions, physical properties (tensile strength, elongation), and barrier integrity.
- Regulatory Requirements: FDA pinhole requirements and sterility assurance levels.
- Labeling Claims: The manufacturer's specific claim of "50ug or less" for protein content.
These are all objective, quantifiable metrics determined by laboratory testing.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML model that requires a training set. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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AUG 0 1 2002
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Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
Telp. 62-61 - 8459160 62-61 - 8459170 62-61 - 8459180 Fax.
"510 (K)" SUMMARY K020040
( 1 ) Name of applicant: Address:
Mr. Hansen Laurence PT. MAJA AGUNG LATEXINDO Jl. Utama No. 98 Puji Mulyo Sunggal - Deli Serdang North Sumatra - Indonesia Phonc No. : (62-61) 845-9170 Fax No. 1 : (62-61) 845-9180
The contact persons within the firm as well as in U.S.A are given below: Contact person in firm: Mr. Hansen Laurence Fax No .: (62-61) 845-9180 Contact person in U.S.A: Emmy Tjoeng Fax No .: (909) 591-8878
(2) Device details Trade Name: Latex Examination Gloves powdered with Oat Starch with protein content labeling claim (50ug or less)
Classification Name: Patient Examination Gloves Powdered
(3) Product Code: 80 LYY
(4) Equivalent device legally marketed: Class I Examination Gloves 80 LYY meeting ASTM D 3578-01
(5) Intended use: Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
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K. 2664
K020040
(6) Technological characteristic of the gloves.
| a. Dimensions | |||||
|---|---|---|---|---|---|
| Sizes | XS | S | M | L | XL |
| Length mm (min.) | 240 | 240 | 240 | 240 | 240 |
| Palm Width mm | $75\pm5$ | $80\pm10$ | $95\pm10$ | $105\pm10$ | $115\pm5$ |
| Thickness | |||||
| 1. Cuff mm (min) | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 |
| 2. Palm mm(min) | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 |
| 3. Finger Tip mm | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 |
b. . Phisycal properties
| Before ageing | After ageing | |
|---|---|---|
| Tensile Strength : | 14 Mpa (min.) | at 70°C 168 hrs14 Mpa (min.) |
| Ultimate Elongation : | 650 % (min.) | 500 % (min.) |
c. Performance requirement
| Characteristic | Related Defects | InspectionLevel | AQL |
|---|---|---|---|
| Sterility | Fails sterility | A | N/A |
| Freedom from holes | Holes | 1 | 2.5 |
| Dimensions& Thickness | Width Length | S-2 | 4 |
| Physical Propertiesafter ageing | Before and | S-2 | 4 |
| Powder Free Residue | Exceeds Maximum Limit | N=5 | N/A |
| Protein Content | Exceeds RecommendedMaximum Limit | N=3 | N/A |
| Powder Amount | Exceeds RecommendedMaximum Limit | N=2 | N/A |
- (7) Performance data is the same as mentioned immediately above.
- (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
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(9) Non-clinical data We certify that the gloves meet or exceed the ASTM D 3578-01 Standard. Meets FDA pinhole requirement. Meets labeling claim. Meets the sterility assurance level.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 1 2002
PT. Maja Agung Latexindo C/O Ms. Emmy Tjoeng Shamrock Marketing Company, Incorporated 5445 Daniel Street Chino, California 91710
Re: K020040
Trade/Device Name: Latex Pre-powdered (Oat Starch) Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 6, 2002 Received: July 2, 2002
Dear Ms. Tjoeng:
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 - Mr. Tjoeng
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180
Applicant: Device Name: PT. Maja Agung Latexindo Latex Examination Gloves powdered with Oat Starch with Protein Content Labeling Claim (50 µg or less)
Indication for use:
Prepowdered latex examination glove is a disposable device intended for medical purpose Frepowdered fatex examiner's hand to prevent contamination between patient and examiners.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chia S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.