(206 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is a glove intended to prevent contamination, not to treat or alleviate a medical condition.
No
The device is a prepowdered latex examination glove, worn on the examiner's hand to prevent contamination. Its function is to provide a barrier, not to diagnose a condition or disease.
No
The device description clearly states it is a "Prepowdered latex examination glove," which is a physical, hardware device. There is no mention of software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens taken from the human body.
- Device Description: The description reiterates the same intended use.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
- Predicate Device: The predicate device is "Class I Examination Gloves," which are not IVDs.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is purely a physical barrier.
N/A
Intended Use / Indications for 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.
Product codes
LYY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Class I Examination Gloves 80 LYY meeting ASTM D 3578-01
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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AUG 0 1 2002
Image /page/0/Picture/1 description: The image shows a stylized logo or graphic with the letters "ma" in a cursive or handwritten style. The letters are bold and connected, with the "m" having two distinct humps and the "a" following smoothly. The background consists of horizontal lines that run across the image, creating a striped effect behind the letters. The bottom left corner of the image is filled with a solid black square, providing a contrast to the lined background and the white letters.
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.
1
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 hrs |
| 14 Mpa (min.) | ||
| Ultimate Elongation : | 650 % (min.) | 500 % (min.) |
c. Performance requirement
| Characteristic | Related Defects | Inspection
Level | AQL |
|-------------------------------------|--------------------------------------|---------------------|-----|
| Sterility | Fails sterility | A | N/A |
| Freedom from holes | Holes | 1 | 2.5 |
| Dimensions
& Thickness | Width Length | S-2 | 4 |
| Physical Properties
after ageing | Before and | S-2 | 4 |
| Powder Free Residue | Exceeds Maximum Limit | N=5 | N/A |
| Protein Content | Exceeds Recommended
Maximum Limit | N=3 | N/A |
| Powder Amount | Exceeds Recommended
Maximum 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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(2000) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1)
(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
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three birds in flight, arranged in a stacked formation.
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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Image /page/5/Picture/0 description: The image shows a close-up of a symbol or logo, possibly handwritten, against a background of horizontal lines. The symbol appears to be stylized letters, possibly 'Ma', with a flowing, connected script. The background lines add a textured effect, and the symbol is framed by a dark, solid border on the left and bottom.
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)