(81 days)
A surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hands during surgical operations to prevent contamination between patient surgeon's
Latex Surgeon's Gloves Pre-Powdered Sterile
The provided document is a 510(k) summary for "Latex Surgeon's Gloves Pre-Powdered Sterile" from PT. MAJA AGUNG LATEXINDO. It details the device's characteristics, performance criteria, and a statement that the performance data meets these criteria.
Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Before ageing) | Acceptance Criteria (After ageing at 70°C 168 hrs) | Reported Device Performance (Implied) |
|---|---|---|---|
| Dimensions: | Meets ASTM D 3577 Standard | ||
| Length mm (min.) Sizes | 265 | N/A | Reported as meeting criteria |
| Palm Width mm (for sizes) | $83 \pm 6$ to $108 \pm 6$ | N/A | Reported as meeting criteria |
| Thickness 1. Cuff mm (min) | 0.10 | N/A | Reported as meeting criteria |
| Thickness 2. Palm mm(min) | 0.10 | N/A | Reported as meeting criteria |
| Thickness 3. Finger Tip mm | 0.10 | N/A | Reported as meeting criteria |
| Physical Properties: | Meets ASTM D 3577 Standard | ||
| Tensile Strength | 24 Mpa (min) | 18 Mpa (min) | Reported as meeting criteria |
| Ultimate Elongation | 750 % (min.) | 560 % (min.) | Reported as meeting criteria |
| Stress at 500 % Elongation | 5.5 (max) | N/A | Reported as meeting criteria |
| Performance Requirements: | |||
| Watertight (Holes) | AQL 1.5 | N/A | Meets FDA pin hole requirement |
| Dimensions | AQL 4.0 | N/A | Reported as meeting criteria |
| Physical Properties | AQL 4.0 | N/A | Reported as meeting criteria |
| Sterility | Not Acceptable for Fails Sterility | N/A | Meets the sterility assurance level |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the test set. It refers to "Inspection Level S-4" and "S-2" and "AQL" values for performance characteristics, which imply sampling plans were used according to standards like ASTM or ISO, but the exact number of units tested is not provided.
- Data Provenance: The data appears to be from the manufacturer, PT. MAJA AGUNG LATEXINDO, based in Indonesia. The nature of the data (retrospective or prospective) is not specified, but it represents testing conducted to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The established ground truth for performance characteristics is based on objective measurements and adherence to ASTM D 3577 and FDA requirements, rather than expert consensus on subjective findings.
4. Adjudication method for the test set
This information is not provided in the document. Given the objective nature of the tests (dimensions, tensile strength, elongation, watertightness, sterility), an adjudication method in the context of expert review would likely not be applicable. The results would be a direct measurement against the specified criteria.
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 MRMC study was done. This device is a physical product (latex surgeon's gloves), not an AI-assisted diagnostic or therapeutic tool. Therefore, a study comparing human reader performance with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As the device is a physical product, there is no algorithm or AI component to perform in a standalone manner.
7. The type of ground truth used
The ground truth used for this device is based on objective measurement against established industry standards and regulatory requirements.
- ASTM D 3577 Standard: For dimensions and physical properties.
- FDA pin hole requirement: For watertightness.
- Sterility Assurance Level: For sterility.
These are well-defined, quantitative standards.
8. The sample size for the training set
- Not applicable. This device is a physical product; there is no machine learning model or algorithm that requires a "training set" in the conventional sense. The product design and manufacturing processes are likely informed by industry experience and engineering principles rather than a data-driven training set.
9. How the ground truth for the training set was established
- Not applicable. As explained above, there is no training set for this type of device. The "ground truth" for ensuring the quality of the manufacturing process would be established through quality control procedures, adherence to Good Manufacturing Practices (GMP), and material specifications, all designed to meet the performance standards.
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Image /page/0/Picture/0 description: The image shows the date November 5, 1999. The month is abbreviated to NOV. The day is the number 5. The year is 1999.
Image /page/0/Picture/2 description: The image shows a close-up of the word "Ma" written in a stylized, cursive font. The letters are bold and black, contrasting with the white background. Horizontal lines run across the top portion of the image, creating a textured effect behind the letters. A black border is visible at the bottom and left side of the image, framing the word.
PT. MAJA AGUNG LATEXINDO MANUFACTURING OF LATEX GLOVES
Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180
Page Numbers 1 of 2
"510 (K)" SUMMARY
| (1) Name of applicantAddress | : Mr. Hansen Laurence: PT. MAJA AGUNG LATEXINDOJl. H. Yamin No. 40 - 40 AMedan 20234IndonesiaPhone No. : 62-61-328888 ; 62-61-859170Fax No. : 62-61-520588 ; 62-61-520588 |
|---|---|
| The contact persons within the firm as well as in U.S.A are given below: | |
| Contact person in firm | : Mr. Hansen LaurenceFax No. : 62-61-520588 : 62-61-859180 |
| Contact person in U.S.A | : Emmy TjoengFax No. : 626-913-1498 |
| (2) Device detailsTrade Name | : Latex Surgeon's Gloves Pre-PowderedSterile |
| Classification Name | : Latex Surgeon's Gloves Pre-PowderedSterile |
| (3) Product Code | : 79 KGO |
| (4) Equivalent device legallymarketed | : Class I Surgeon's Gloves 79 KGOmeeting ASTM D 3577 - Sterilizedby gamma radiation |
| (5) Intended use | : A surgeon's glove is a disposable device intended formedical purpose that is worn on surgeon's hands duringsurgical operations to prevent contamination betweenpatient surgeon's |
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Image /page/1/Picture/1 description: The image shows a stylized logo with the letters "Ma" in a cursive font. The letters are black and stand out against a background of horizontal lines. The left side of the logo has a thick black vertical bar, and the bottom of the logo has a thick black horizontal bar.
PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180
Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
| a. DimensionsSizes | 6½ | 7 | 7½ | 8 | 8½ |
|---|---|---|---|---|---|
| Length mm (min.) | 265 | 265 | 265 | 265 | 265 |
| PalmWidth mm | $83\pm6$ | $89\pm6$ | $95\pm6$ | $102\pm6$ | $108\pm6$ |
| Thickness1. Cuff mm (min) | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 |
| 2. Palm mm(min) | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 |
| 3. Finger Tip mm | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 |
b. Physical Properties
| Before ageing | After ageingat 70°C 168 hrs | |
|---|---|---|
| Tensile Strength | : 24 Mpa (min) | 18 Mpa (min) |
| Ultimate Elongation | : 750 % (min.) | 560 % (min.) |
| Stress at 500 % Elongation | : 5.5 (max) | : |
c. Performance Requirement
| Characteristic | Related Defects | InspectionLevel | AQL |
|---|---|---|---|
| Watertight | Holes | S-4 | 1.5 |
| Dimensions | Width Length& Thickness | S-2 | 4.0 |
| Physical Properties | Before andafter ageing | S-2 | 4.0 |
| Sterility | Fails sterility | Not Acceptable |
- (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.
- (9) Non-clinical data
We certify that the gloves meet or exceed the ASTM D 3577Standard Meets FDA pin hole requirement. Meets labeling claim. Meets the sterility assurance level.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MUN - 5 1999
PT. Maja Aqunq Latexindo c/o Ms. Emmy Tjoeng Official Correspondent for PT. Maja Aqunq Latexindo Shamrock Marketing Company, Incorporated 889 South Azusa Avenue City of Industry, California 91748
Re : K992752 Trade Name: Pre-Powdered Sterile Latex Surgeon's Gloves Requlatory Class: I Product Code: KGO Auqust 11, 1999 Dated: Received: August 16, 1999
Dear Ms. Tjoeng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Tjoenq
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Clutrust
thy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '992752'. The digits are written in a simple, slightly irregular style, typical of handwriting.
Image /page/4/Picture/1 description: The image shows a close-up of the letters 'Ma' in a stylized font. The letters are black and are set against a background of horizontal lines. The letters are bold and have a rounded appearance.
MAJA AGUNG LATEXIN
MANUFACTURING OF LATEX GLOVE
Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180
ANNEXURE II
INDICATION FOR USE
| Applicant | : Mr. Hansen Laurence |
|---|---|
| Device Name | : Latex Surgeon's Gloves Pre-PowderedSterile |
| Indication for use | : |
A latex surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hand during surgical operation to prevent contamination between patient and surgeon.
(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) | |
| Division Sign-Off | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K992752 |
| Over-The-Counter Use | X |
| (Optional Format 1-2-96) |
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).