(128 days)
Class I Latex Examination Gloves 80 LYY Powder Free with Protein Claim meeting ASTM D 3578 – 95
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML technology.
No
This device, a patient examination glove, is intended for preventing contamination, not for treating a disease or condition.
No
A patient examination glove is used for protection from contamination, not for diagnosing medical conditions.
No
The device is a physical product (gloves) and the description focuses on material properties and performance standards for a physical object, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners." This describes a barrier device used externally.
- Device Description: The description is "Latex Examination Gloves Powder Free with Protein Claim." This is consistent with a physical barrier device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Data: The performance data focuses on physical properties like tensile strength, elongation, watertightness, and protein content, which are relevant to the integrity and barrier function of a glove, not diagnostic performance.
Therefore, this device falls under the category of a medical device used for protection and contamination prevention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient 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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
- (6) Performance data is the same as mentioned immediately above.
- (7) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (8) Non-clinical data Gloves meet or exceed the ASTM Standard. Meets FAD pin hole requirement. Meets labeling claim.
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 Powder Free with Protein Claim meeting ASTM D 3578 – 95
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.
0
DEC 23 398
Image /page/0/Picture/1 description: The image shows a stylized logo or design featuring the letters "ma" in a cursive or handwritten style. The letters are positioned above a thick, black horizontal bar. Above the letters, there are several horizontal lines that create a striped effect. The overall design is simple and graphic, with a focus on the contrast between the black elements and the white background.
K 982897 PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
62-61 - 859160 Telp. 62-61 - 859170 Fax. 62-61 - 859180
Page Numbers 1 of 2
"510 (K)" SUMMARY
| (1) Name of applicant
Address | : Mr. Hansen Laurence
: PT. MAJA AGUNG LATEXINDO
Jl. H. Yamin No. 40 – 40 A
Medan 20234
Indonesia
Phone No.
Fax No. | : 62-61-328888 ; 62-61-859170
: 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 Laurence
Fax No. | : 62-61-520588 ; 62-61-859170 |
| Contact person in U.S.A | : Emmy Tjoeng
Fax No. | : 562-693-8866 |
| (2) Device details | | |
| Trade Name | | : Latex Examination Gloves
Powder Free with Protein Claim |
| Classification Name | | : Patient Examination Gloves |
| Product Code | | : Latex 80 LYY |
| (1) Equivalent device legally
marketed | | : Class I Latex Examination Gloves 80 LYY
Powder Free with Protein Claim
meeting ASTM D 3578 – 95 |
| (4) Intended use | | : A patient 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 |
1
Kg82897
Image /page/1/Picture/1 description: The image shows a logo with the letters "Ma" in a stylized font. The letters are black and appear to be handwritten or calligraphic. The background behind the letters consists of horizontal lines, creating a striped effect. The left side of the logo has a solid black shape, possibly a square or rectangle, that partially obscures the background lines.
PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
62-61 - 859160 Telp. 62-61 - 859170 Fax. 62-61 - 859180
Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
Page Numbers 2 of 2
| (5) Technological characteristic of the gloves. | ||||
|---|---|---|---|---|
| a. Dimensions | ||||
| Sizes | Small | Medium | Large | |
| Length (min.) | 240 mm | 240 mm | 240 mm | |
| Palm Width thickness | 85±10 mm | 95±10 mm | 111±10 mm | |
| 1. Cuff (min) | 0.10 mm | 0.10 mm | 0.10 mm | |
| 2. Palm (min) | 0.10 mm | 0.10 mm | 0.10 mm | |
| 3. Finger Tip (min) | 0.10 mm | 0.10 mm | 0.10 mm | |
| b. Physical Properties | ||||
| Before ageing | After ageing at 70°C 168 hrs. | |||
| Tensile Strength | : | 21 Mpa | 16 Mpa | |
| Ultimate Elongation | : | 700 % (min.) | 600 % (min.) | |
| c. Performance Requirement | ||||
| Characteristic | Related Defects | Inspection Level | AQL | |
| Watertight | Holes | S-4 | 2.5 | |
| Dimensions | Width Length & Thickness | S-2 | 4 | |
| Physical Properties | Before and after ageing | S-2 | 4 | |
| d. | Weight of residual powder in medium size gloves : 0.50 ± 0.20 mg | |||
| e. | Total water extractable protein 50 microgram/gram (maximum) | |||
| f. | Bio-Compatibility (attached) | Annexure XII | ||
| g. | Test Results as per ASTM D 3578 - 95 (attached) | Annexure V |
- (6) Performance data is the same as mentioned immediately above.
- (7) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (8) Non-clinical data Gloves meet or exceed the ASTM Standard. Meets FAD pin hole requirement. Meets labeling claim.
2
K 4782897
MATERIALS USED FOR THE PRODUCTION OF LATEX EXAMINATION GLOVES POWDER - FREE WITH PROTEIN CLAIM
| Dry Weight | |
|---|---|
| 60 % Concentrated Natural Rubber Latex | - 100 |
| KOH Solution | - 0.10 |
| Zinc diethyl dithiocarbamate | - 0.50 |
| Zinc dibutyl dithiocarbamate | - 0.30 |
| Zinc oxide | - 0.75 |
| Sulphur | - 0.80 |
| Titanium dioxide | - 0.60 |
| BHT | - 1.50 |
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EE 2 3 1936
P.T. Maja Agung Latexindo C/O Ms. Emmy Tjoenq Official Correspondent Glove Source, Incorporated 345 Cloverleaf Drive, Suite B Baldwin Park, California 91706
Re : K982897 Powder-Free Latex Examination Glove with Trade Name: Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY November 25, 1998 Dated: November 27, 1998 Received:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
4
Page 2 - Ms. Tjoeng
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 findinq 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 requlation (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"(21CFR 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/dsma/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows a logo with the letters 'ma' in a stylized font. The letters are overlapping and appear to be drawn with thick lines. The background behind the letters consists of horizontal lines, creating a striped effect. The bottom portion of the image is a solid black rectangle, providing a base for the logo.
PT. MAJA AGUNG LATI
MANUFACTURING OF LATEX GLOV
Jin. Utama No. 98 PUJi MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
62-61 - 85916 Telp. 62-61 - 8591. Fax. 62-61 - 8591
ANNEXURE II
INDICATION FOR USE
| Applicant | : Mr. Hansen Laurence |
|---|---|
| Device Name | : Latex Patient Examination Gloves Powder Free With Protein |
| Indication for use | : Content Labeling Claim ( 50 micrograms or less ) |
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 examiners.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S. Barrett for Ckn
(Division Sign-Off) Division of Death, infection . Satrol, and General Hospital Devices 510(k) Number .
Prescription Use ( Per 21 CFR 801. 109 ) OR
Over-The-Counter Use
( Optional Format 1-2-96 )