(28 days)
Not Found
Not Found
No
The device is a disposable examination glove, and the summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device, "Powder free Latex Examination Gloves with Grape," is intended for contamination prevention, not for therapy, diagnosis, treatment, or mitigation of disease.
No
The device description indicates it is an examination glove used to prevent contamination, which is a barrier function, not a diagnostic one.
No
The device is described as physical gloves worn on the hand, not software.
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 to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reiterates the intended use and function, which is a physical barrier.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a medical glove, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Powder free Latex Examination Gloves with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Product codes
80 LYY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
(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.
(9) Non-clinical data We certify our gloves meet or exceed the ASTM D 3578-01ae2 Standard. Meets FDA pinhole requirement. Meets labeling claim.
Key Metrics
Not Found
Predicate Device(s)
Class I Examination Gloves 80 LYY meeting ASTM D 3578-01ae2
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
Image /page/0/Picture/0 description: The image shows a logo with a four-leaf clover in the background. The letters 'SMC' are written across the clover. The logo is circular and has a black and white color scheme. The image appears to be a scan of a printed document.
PT. Shamrock
Manufacturing
Corpor
Image /page/0/Picture/2 description: The image contains two logos. The logo on the left has a triangle with the words "Tov Rheinland Product Safety" underneath. The logo on the right has the letters "GM" with a medical symbol in the middle of the letters.
Image /page/0/Picture/3 description: The image shows a close-up of a logo or emblem, possibly related to a certification or quality standard. The logo includes the letters "TUV" in a stylized font, along with the text "EN ISO 9002". The text is small and somewhat difficult to read, but it appears to be part of a certification mark.
Image /page/0/Picture/4 description: The image contains a CE marking, which consists of the letters 'C' and 'E' in a specific form. The CE marking is a symbol indicating that a product meets the health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The marking is often found on a wide range of products, including electronics, toys, and machinery, to demonstrate compliance with EU regulations.
Page Numbers 1 of 2
"510 (K)" SUMMARY
MAR 2 1 2003
(1) Name of applicant Address
: DR. SUPENO SURYA, MBA PhD : PT. SHAMROCK Manufacturing Corp. Jl. Pemuda No. 11 Medan 20151 - Indonesia Phone No. : 62-61-4558888 Fax No. : 62-61-4520588
Contact person in U.S.A
: Emmy Tjoeng Fax No. : 909-591-8878
- (2) Device details Trade Name
: Powder free Latex Examination Gloves with Grape Centains souncym or less of total syfracts
Classification Name
: Powder free Latex Examination Gloves with Grape
-
(3) Product Code
: 80 LYY -
(4) Equivalent device legally marketed
: Class I Examination Gloves 80 LYY meeting ASTM D 3578-01ae2
OFFICE :
Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone (62-61) 455 8888 (Hunting) - 452 0688 - 452 6688 - 4520638 Fax. (62-61) 452 0588 E-mail : smc@shamrock-id.com
FACTORY : .
Jl. Raya Medan - Namorambe Ps. IV Kab. Deli Serdang Phone (62-61) 703 0008 Fax. (62-61) 703 0007 E-mail : shamrock@indosat.net.id.
1
Image /page/1/Picture/0 description: The image shows a logo with a four-leaf clover in a circle. The letters "MC" are written across the clover. The logo is black and white and has a vintage look.
r. Shamrock Manufacturing
Image /page/1/Picture/2 description: The image contains two logos side by side. The logo on the left has a triangle with two curved lines inside, along with the text "TUV Rheinland Product Safety". The logo on the right has the letters "GM" in a stylized font, with additional text below and to the right of the letters. The text below the letters appears to be "Guarantee Mark Corporation" and "Approved medical system".
Image /page/1/Picture/3 description: The image shows a logo with the text "TUV CERT" in a stylized font. Below the logo, the text "DIN EN ISO 9002" is printed. The text "Certificate 01 100 00074" is printed below that. The logo and text are enclosed in a rectangular border.
Image /page/1/Picture/4 description: The image shows a white square with rounded corners. Inside the square are the letters 'CE' in bold, black font. The letters are stacked horizontally, with the 'C' on the left and the 'E' on the right. This is the CE marking, a symbol indicating conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
Page Numbers 2 of 2
K030560
F
- (5) Intended use
: Powder free Latex Examination Gloves with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
(6) Technological characteristic of the gloves.
a. Dimensions
| Sizes | Small | Medium | Large | X-Large |
|---|---|---|---|---|
| Length mm (min.) | 220 | 230 | 230 | 230 |
| Palm Width mm | $80\pm10$ | $95\pm10$ | $111\pm10$ | $120 \pm10$ |
| Thickness | ||||
| 1. Cuff mm (min) | 0.08 | 0.08 | 0.08 | 0.08 |
| 2. Palm mm (min) | 0.08 | 0.08 | 0.08 | 0.08 |
| 3. Finger Tip mm | 0.08 | 0.08 | 0.08 | 0.08 |
| b. Physical Properties | ||||
| Before ageing | After ageing | |||
| at 70°C 168 hrs. | ||||
| Tensile Strength | : 18 MPa (min) | 14 MPa (min) | ||
| Ultimate Elongation | : 650 % (min.) | 500 % (min.) |
- (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.
- (9) Non-clinical data We certify our gloves meet or exceed the ASTM D 3578-01ae2 Standard. Meets FDA pinhole requirement. Meets labeling claim.
44
OFFICE :
Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone (62-61) 455 8888 (Hunting) - 452 0688 - 452 6688 - 4520631 Fax. (62-61) 452 0588 E-mail : smc@shamrock-id.com
FACTORY : .
JI. Raya Medan - Namorambe Ps. IV Kab. Deli Serdang Phone (62-61) 703 0008 Fax. (62-61) 703 0007 E-mail : shamrock@indosat.net.id.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2003
PT. Shamrock Manufacturing Corporation C/O Ms. Emmy Tjoeng Official Correspondent Shamrock Marketing Company, Incorporated 5445 Daniels Street Chino, California 91710
Re: K030560
Trade/Device Name: Powderfree Latex Examination Gloves with Grape Aroma Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: February 18, 2003 Received: February 21, 2003
Dear Ms. Emmy 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.
3
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), please contact the Office of Compliance at (301) 594-46__ Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Susan Runner, DDS, MA
Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Image /page/4/Picture/0 description: The image shows a black and white logo with the letters "SMC" in a stylized font superimposed over a four-leaf clover. The clover and letters are contained within a circle. The logo has a slightly distressed or vintage appearance, with some areas of the image appearing faded or worn.
Image /page/4/Picture/1 description: The image shows the text "PT. Shamrock Manufacturing Corpora". The text is in a bold, sans-serif font. The words are stacked on top of each other, with "PT. Shamrock" on the top line, "Manufacturing" on the second line, and "Corpora" on the third line. The text is black and the background is white.
Image /page/4/Picture/2 description: The image shows four different certification logos. The first logo is the "TUV Rheinland Product Safety" certification mark, which features a triangle above the text. The second logo is a medical device certification mark. The third logo is the "TUV CERT DIN EN ISO 9002" certification mark, with the certificate number 01 100 006971. The fourth logo is the CE marking, which indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
Ko 3052d
ANNEXURE II
INDICATION FOR USE
Applicant Device Name Indication for use
: PT. SHAMROCK Manufacturing Corp. : Powderfree Latex Examination Gloves with Grape. Four : Contains so migm ac less of fotal Water Extrac
favor Powderfree Latex Examination Gloves with Grape is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination betyeen patient and examiner.
(signature)
DR.SUPENO SURYA, MBA PhD
(Type Name) Feb 18, 2003
(date)
Olin S. Lim
(Division Sign-Off) (Division Sign of Anesthesiology) (Division of Anestal Division Control, Dent
510(k) Number: K03052
OFFICE: Jl. Pemuda No. 11 Medan - 20151 - Indonesia Phone (62-61) 455 8888 (Hunting) - 452 0688 - 4520638 Fax. (62-61) 452 0588 E-mail : smc@shamrock-id.com