(85 days)
Not Found
Not Found
No
The device description and intended use clearly define the device as a latex examination glove, which is a physical barrier device. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The performance studies focus on physical properties and sterility, not algorithmic performance.
No
The device, a latex examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device, a latex examination glove, is intended to prevent contamination between patient and examiner. It does not provide any diagnostic information or aid in the diagnosis of a disease or condition.
No
The device description clearly states it is a physical product (Latex Powder free Sterile Examination Gloves) and the performance studies refer to ASTM standards for gloves, indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is worn on the hand or finger to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description is simply "Latex Powder free Sterile Examination Gloves." This describes a physical barrier, not a reagent, instrument, or system used for diagnosis.
- Lack of Diagnostic Elements: The document does not mention any of the typical components or functions of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
- Performance Studies: The performance studies focus on physical properties like pinhole requirements, labeling claims, and sterility assurance level, which are relevant to a barrier device, not a diagnostic test.
- Predicate Device: The predicate device is also described as "Class I Latex Examination Gloves," reinforcing that this is a glove, not an IVD.
In summary, the purpose of this device is to provide a physical barrier for protection, not to perform a diagnostic test in vitro.
N/A
Intended Use / Indications for Use
A latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners
A sterile latex powderfree 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 examiners.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Latex Powder free Sterile Examination Gloves. Dimensions: Length 240 mm (all sizes XS-XL), Width (XS) 75 plus/minus 5 mm, (S) 80 plus/minus 10 mm, (M) 00 plus/minus 10 mm, (L) 105 plus/minus 10 mm, (XL) 115 plus/minus 5 mm. Thickness (min) Cuff 0.10 mm, Palm 0.10 mm, Finger Tip 0.10 mm. Physical Properties: Tensile Strength Before ageing 14 Mpa, After ageing at 70 degrees C 168 hrs 14 Mpa. Ultimate Elongation: Before ageing 650 % (min.), After ageing at 70 degrees C 168 hrs 600 % (min.). Performance requirements for Sterility, Freedom from holes, Dimensions & Thickness, Physical Properties after ageing, Powder Free Residue, Protein Content, Powder Amount.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner in a medical purpose setting
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)
Performance data is the same as mentioned immediately above. (referring to technological characteristics under Device Description)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Class I Latex Examination Gloves 80 LYY Pre - Powdered meeting ASTM D 3578 – 01 Sterilized by gamma radiation
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows a stylized logo or graphic. The letters "Ma" are prominently displayed in a bold, sans-serif font. The letters are overlaid on a background of horizontal lines, creating a textured effect. The overall design is simple and modern, with a focus on the typography.
A AGUNG LAT MANUFACTURE OF LATEX GLOVE
Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180
Page Numbers 1 of 2
13996
FEB 2 6 2002 "510 (K)" SUMMARY
| (1) Name of applicant | : Mr. Hansen Laurence |
|---|---|
| Address | : PT. MAJA AGUNG LATEXINDO |
| Jl. Utama No. 98 Puji Mulio | |
| Sunggal -Deli Serdang | |
| North Sumatra - Indonesia | |
| Phone No. | : 62-61-845-9170 |
| Fax No. | : 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 Powder free Sterile Examination Gloves |
| Classification Name | : Latex Powder free Sterile Examination Gloves |
| (3) Product Code | : Latex 80 LYY |
| (4) Equivalent device legally | |
| marketed | : Class I Latex Examination Gloves 80 LYY |
| Pre - Powdered meeting ASTM D 3578 – 01 | |
| Sterilized by gamma radiation | |
| (5) Intended use | : A latex examination glove is a disposable device intended |
| for medical purpose that is worn on examiner's hand or | |
| finger to prevent contamination between patient and | |
| examiners |
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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
Page Numbers 2 of 2
(6) Technological characteristic of the gloves.
| Dimensions
| Sizes | XS | S | M | L | XL |
|---|---|---|---|---|---|
| Length | 240 mm | 240 mm | 240 mm | 240 mm | 240 mm |
| Width | $75\pm5$ mm | $80\pm10$ mm | $00\pm10$ mm | $105\pm10$ mm | $115\pm5$ mm |
| THICKNESS |
- Cuff (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
| 2. Palm (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
| 3. Finger Tip (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
- b. Physical Properties
a.
| | Before ageing | After ageing
at 70°C 168 hrs |
|-----------------------|---------------|---------------------------------|
| Tensile Strength : | 14 Mpa | 14 Mpa |
| Ultimate Elongation : | 650 % (min.) | 600 % (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.
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Image /page/2/Picture/0 description: The image is a black and white logo. The logo has a large letter "L" on the left side. The letter "Ma" is written in cursive on the right side of the logo. The background of the logo has horizontal lines.
MAJA AGUNG LATE
MANUFACTURE OF LATEX GLO
Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
Telp. 62-61 - 8459160 62-61 - 8459170 62-61 - 8459180 Fax.
- (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 3578 - 01 Standard. Meets FDA pinhole requirement. Meets labeling claim. Meets the sterility assurance level.
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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
PT. Maja Agung Latexindo C/O Ms. Emmy T. Joeng Shamrock Marketing Company, Incorporated 5445 Daniel Street Chino, California 91710
Re: K013996
Trade/Device Name: Latex Powderfree Sterile Examiantion Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 29, 2001 Received: December 3, 2001
Dear Ms. Joeng:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becament mined the device is substantially equivalent (for the releveloca above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Antichements, or to do rood alle metic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, Lrag, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include controls providents or a 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 (1 will), it inch be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear. or rouncements concerning your device in the Federal Register.
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.
4
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 (QS) 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Kane
Timothy A. Ulatowski Director 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/5/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized graphic to the left of the company name in bold, sans-serif font. Above the company name is the number 013996.
Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
Telp. 62-61 - 8459160 62-61 - 8459170 62-61 - 8459180 Fax.
ANNEXURE II
INDICATION FOR USE
| Applicant | : Mr. Hansen Laurence |
|---|---|
| Device Name | : Latex Powderfree Sterile Examination Gloves |
| Indication for use | : |
A sterile latex powderfree 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 examiners.
Sisan Pani
(Tivision Sign-Off)
Tivision Sign-Off)
Dontal ("Tivision Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Devienti Division of General Hospital D r 10(k) Number -