(51 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard examination glove, with no mention of AI/ML or related technologies.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or alleviate a disease, injury, or disability.
No
The device is described as a "patient examination glove" intended to "prevent contamination between and patient examiners." This function does not involve diagnosing medical conditions, but rather providing a barrier for hygiene and safety.
No
The device description clearly states it is a physical product (Latex Examination Gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patients and examiners by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's a glove, a physical barrier.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. A patient examination glove does not perform this function.
N/A
Intended Use / Indications for Use
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 and patient examiners.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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): 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.
Not Found
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
Image /page/0/Picture/1 description: The image shows a logo with the word "TATA" at the bottom. Above the word "TATA" is a symbol that appears to be a person standing with their arms outstretched. Above the person is a semi-circular design with lines radiating upwards, resembling the sun. The logo is black and white.
PT. TATA RUBBERINDO INDUSTRIES
11 th. Floor WISMA ARGO MANUNGGAI
11 th. Floor WISMA Key, 22 11 th. Floor WiSambroto Kav. 22 Jakarta - 12930
Factory : Jl. Raya Serang Km. 13.8 . Jl. Raya Select (Hunling) Phone ( 021 ) 5962436
( 021 ) 5962436
Cikupa - Tangerang : Fax.
Page Numbers 1 of 2
"510 (K)" SUMMARY (K991158)
| (1) Name of applicant
Address | : Mr. Andy Tanaka
: PT. Tata Rubberindo Industries
Jl. Raya Serang Km. 13.8
Cikupa - Tangerang
Jakarta - Indonesia
Phone No. 62-21-5962435
Fax No. 62-21-5962436 |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The contact persons within the firm as well as in U.S.A are given below: | |
| Contact person in firm | : Mr. Andy Tanaka
Fax No. 62-21-5962436 |
| Contact person in U.S.A | : Cindy Tung
Fax No. : 626-913-1498 |
| (2) Device details
Trade Name
Classification Name
Product Code | : Latex Examination Gloves - Powder Free
: Patient Examination Gloves
: Latex 80 LYY |
| (3) Equivalent device legally
marketed | : Class I Latex Examination Gloves 80 LYY
Powder - Free meeting ASTM D 3578-95 |
| (4) Intended use | : 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 and patient examiners. |
1
: : ,
(5) Technological characteristic of the gloves.
| a. Dimensions
| Sizes | XS | S | M | L | XL |
|---|---|---|---|---|---|
| Length | 240 mm | 240 mm | 240 mm | 240 mm | 240 mm |
| Width | 80 111mm |
- Thickness
| ﮨﮯ ﺍﻭﺭ ﺍﯾﺮﺍﻥ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ
- Cuff (min) | | 0.10 mm 0.10 mm 0.10 mm | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------|--|
| 2. Palm (min) | | | |
| 3. Finger Tip (min) 0.10 mm 0.10 mm 0.10 mm 0.10 mm 0.10 mm | | | |
- b. Physical Properties
| Tensile Strength: | Before aging | After aging
at 70°C 168 hrs. |
|----------------------|--------------|---------------------------------|
| | 21 Mpa | 16 Mpa |
| Ultimate Elongation: | 700 % (min.) | 600 % (min.) |
:
1000
-
(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 We certify that these gloves meet ASTM D 3578 Standard. Meets FDA pinhole requirement. Meets labeling claim.
30
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring a staff with a snake winding around it.
TUL I a 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PT. Tata Rubberindo Industries C/O Mr. Andy Tanaka Jl. Raya Serang Km. 13.8 Cikupa - Tangerang INDONESIA
K991158 Re: Latex Examination Gloves - Powder Free Trade Name: Regulatory Class: I Product Code: LYY May 12, 1999 Dated: Received. My 14, 1999
Dear Mr. Tanaka:
This letter corrects our substantially equivalent letter of May 28, 1999 regarding the address.
We have reviewed your Section 510(k) notification of intent to
r have and the bling bline for your device on our labeling We have reviewed your Section 510\/ hockrice on our labeling
market the device ific advice for your device on our labeling market the device fric advice tor goals and additionally 809.10 for in
regulation (21 CFR Part) plance contact the Office of regulation (21 crk rare over anase contact the Office of vitro diagnostic devices), please concase concasso de compliance on Compliance at (301) 394-4692. And one devices that have been
che promotion and advertising of your and the Pedera. the promotion and advertising of your actives of the Pederal
reclassified in accordance with the provisions of the Pederal reclassified in accordance with one from may, therefore, Food, Drug, and Cosmetic Acc (no, a meral controls provisions
market the device, subject to the general controls provisions of the Act The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of include requirements furing practice, labeling, and nevices, good manufacturers misbranding and adulteration.
If your device is classified (see above) into either class II If your device Is classifica (bee assocrited Approval) it may be (Special controls) additional controls. Existing major subject to such addrerenar device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ rederal Regulations, freis as mination assumes compliance with Substancially equivalent active requirements, as set forth in the Good Manufacturing lation (QS) for Medical Devices: Che Quality Oyacem Rogara21 ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . periodic QS inspections, FDA will verify such assumptions.
3
Page 2 - Mr. Tanaka
Failure to comply with the GMP regulation may result in railure to comply ... In addition, the Food and Drug regulatory accion. In augublish further announcements concerning your device in the Federal Register. Please note: concerning your device in entere in submission does chis response to your promosou might have under sections 531 not arrect any obrigation your ces under the Electronic through 542 of the net 101 acrises or other Federal laws or regulations .
This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA as described in your 510 (i) please of your device to a legally Finding of Subbeancear oquires in a classification for your marketed predicate active 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 onting draghosere devisor) - Establionally, for questions on Compriance at (301) yertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 2018 11:56 obcainca toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely,
Timothy A. Ulatowski
Timot Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the TATA group logo. The logo features a stylized figure standing with arms outstretched, positioned above the word "TATA". The figure is set against a backdrop of radiating lines, resembling a sunrise or a burst of energy. The logo is black and white.
PT TATA RUBBERINDO INDUSTRIES
Floor WISMA ARGO MANUNGGAL Ji. Jend. Gatot Subroto Kav. 22 Jakarta - 12930
02115962436 kupa - Tange
ANNEXURE II
INDICATION FOR USE
: Mr. Andy Tanaka Applicant : Latex Patient Examination Gloves Powder Free Device Name Indication for use :
Image /page/4/Picture/8 description: The image shows a black circle on a white background. The circle is solid black, and there are a few small white spots within the circle. The white spots are irregularly shaped and scattered throughout the circle. The background is plain white.
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)
Qlim S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 5 : O(k) Number
Prescription Use (Pcc 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Forms: 1-2-96)
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