(52 days)
80 LYY
Not Found
No
The 510(k) summary describes a standard examination glove and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance data focuses on material standards and sterility, not algorithmic performance.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat a disease or condition.
No
The device is described as an examination glove, which is used to prevent contamination, not to diagnose medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination. This is a physical barrier device used during medical procedures.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro) to provide information about a person's health.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes. The device's function is purely a physical barrier.
Therefore, based on the provided information, this device is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
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 that require a sterile procedure.
A latex 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 that require a sterile procedure.
Product codes
Latex 80 LYY, 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 / medical purpose
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 deared by the 510 (K) process.
- (8) Non-dinical data Gloves meet or exceed the ASTM D 3578 Standard. Meets FDA pin hole requirement. Meets labeling daim. Meets the sterility assurance level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Class I Latex Examination Gloves 80 LYY Pre-Powdered meeting ASTM D 3578-95
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.
0
FEB
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 bold and black, contrasting with the white background. The background consists of horizontal lines that add a textured effect to the image. The overall design is simple yet eye-catching, with the bold letters and contrasting background creating a visually appealing image.
PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 859 62-61 - 859 Fax. 62-61 - 859
Page Numbers 1 of 2
K 994255
"510 (K)" SUMMARY
| (1) Name of applicant | : Mr. Hansen Laurence |
|---|---|
| Address | : PT.Maja Agung Latexindo |
| JI.H. M. Yamin No. 40-40 A | |
| Medan | |
| Indonesia | |
| Phone No. | 62-61-328888; 62-61-859170 |
| Fax 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 Laurence
Fax No.: 62-61-520588 62-61-8459180 |
|-------------------------|--------------------------------------------------------------|
| Contact person in U.S.A | : Emmy Tjoeng
Fax No.: 626-913-1498 |
| (2) Device details | |
|---|---|
| Trade Name | : Private lebel-Latex Examination Gloves Pre - Powdered |
| Classification Name | : Patient Examination Gloves |
| Product Code | : Latex 80 LYY |
| (3) Equivalent device legally marketed | : Class I Latex Examination Gloves 80 LYY
Pre-Powdered 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 that require a sterile procedure. |
|---|---|
| ------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/1/Picture/0 description: The image shows a stylized logo with the letters "Ma" in a cursive font. The letters are bold and black, contrasting with the white background. Horizontal lines run across the top portion of the logo, creating a striped effect behind the letters. The bottom left corner of the logo is filled with a solid black square, providing a visual anchor and adding depth to the design.
PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
OF LATEX GLOVES
Telp. 62-61 - 85916 62-61 - 85917 Fax. 62-61 - 85918
Page Numbers 2 of 2
Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
| (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 | |||||||
| 1. 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 | ||||||
| Before ageing | After ageing | ||||||
| at 100°C 22 hrs. | |||||||
| Tensile Strength | |||||||
| Ultimate Elongation | 21 Mpa (min.) | ||||||
| 700 % (min.) | 16 Mpa (min.) | ||||||
| 600 % (min.) | |||||||
| c. | Performance Requirement | ||||||
| Characteristic | Related Defects | Inspection | |||||
| Level | AQL | ||||||
| Visible defects | Stains, Lumps, | ||||||
| Holes etc. | S-4 | 2.5 | |||||
| Watertight | Holes | S-4 | 1.5 | ||||
| Dimensions | Width Length | ||||||
| & Thickness | S-2 | 4 | |||||
| Physical Properties | Before and | ||||||
| after ageing | S-2 | 4 | |||||
| Sterility | Fails sterility | Not Acceptable |
- (6) Performance data is the same as mentioned immediately above.
- (7) Clinical date is not needed for Gloves or for most devices deared by the 510 (K) process.
- (8) Non-dinical data Gloves meet or exceed the ASTM D 3578 Standard. Meets FDA pin hole requirement. Meets labeling daim. Meets the sterility assurance level.
રેર
2
ANNEXURE XI
: 上一篇:
۲۰۰:
MATERIALS USED FOR THE PRODUCTION OF LATEX EXAMINATION GLOVES - PRE-POWDERED
| Dry Weight | |
|---|---|
| 60 %Concentrated Natural Rubber Latex | - 100 |
| Zinc diethyl dithiocarbamate | - 0.50 |
| Zinc dibutyl dithiocarbamate | - 0.30 |
| Zinc oxide | - 0.75 |
| Sulphur | - 0.80 |
| KOH Solution | - 0.10 |
| Titanium dioxide | - 0.60 |
| BHT | - 1.50 |
3
Image /page/3/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 FEB
PT. Maja Agung Latexindo c/o Mr. Emmy Tjoeng Official Correspondent for PT. Maja Aqunq Latexindo Shamrock Marketing Company, Incorporated 889 South Azusa Avenue City of Industry, California 91748
Re : K994255 Latex Examination Gloves Pre-powdered Trade Name: Sterile Requlatory Class: I Product Code: LYY December 15, 1999 Dated: December 17, 1999 Received:
Dear Mr. 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 general controls provisions The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ರ್ಥ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
4
Page 2 - Mr. Tjoeng
the Federal Register. Please note: this response to your premarket notification submission does not affect any premailor 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 marketou production overmits 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" (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,
Timothy A. Ulatowski
Timothy A. Ulatowski 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 black and appear to be handwritten or calligraphic. The background consists of horizontal lines, creating a striped effect behind the letters. A solid black block is positioned to the left of the letters, adding a contrasting element to the design.
PT. MAJA AGUNG LATEXIND
MANUFACTURING OF LATEX GLOVES
Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 85 62-61 - 85 Fax. 62-61 - 85
ANNEXURE II
INDICATION FOR USE
Applicant Device Name : Mr. Hansen Laurence : Latex Examination Gloves Pre-Powdered Sterile
Indication for use
A latex 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 that require a sterile procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
P.T. Julia Aguing
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcc 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Qain S. Lin
Division of Dental, Infection Cont
(Division Sign-Off)
and General Hospita 510(k) Number