(70 days)
Class I Examination Gloves 80 LYY meeting ASTM D 3578-01ae2
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related concepts like image processing or training/test sets.
No
The device is a glove intended to prevent contamination, not to treat or diagnose a medical condition.
No
Explanation: The device is a latex examination glove, which is used for preventing contamination. It does not perform any diagnostic functions like detecting, monitoring, or predicting diseases or conditions.
No
The device is a physical examination glove, not a software application. The description clearly states it is a "disposable device intended for medical purpose that is worn on examiner's hand".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 externally.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such tests.
- Device Description: The description is for a glove, which is a physical barrier, not a diagnostic tool.
- Lack of Diagnostic Information: The document lacks any mention of analyzing samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Latex Examination Gloves Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
80 LYY
Device Description
Latex Examination Gloves Powder Free With Lined. Latex Examination Gloves Powder Free with Neoprene Lined.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 the technological characteristics table on page 1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 Examination Gloves 80 LYY meeting ASTM D 3578-01ae2
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.
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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 logo with the letters "SMC" superimposed over a four-leaf clover. The clover is positioned inside a circle. The letters "SMC" are horizontally aligned across the center of the clover. The logo appears to be a vintage or retro design, with a slightly distressed or aged look.
Address
Image /page/0/Picture/1 description: The image shows the text "Ft. Shamrock Manufacturing Corpora" in a bold, distressed font. The text is arranged in three lines, with "Ft. Shamrock" on the top line, "Manufacturing" on the second line, and "Corpora" on the third line. The font style gives the text a rough, textured appearance.
Image /page/0/Picture/2 description: The image contains two logos side by side. The logo on the left has a triangle with two horizontal lines inside of it, and below the triangle is the text "TUV Rheinland Product Safety". The logo on the right has a stylized "GN" with a caduceus symbol on top of the letters. Below the letters is the text "Global-Tec Hygiene Approved Medical Device".
Image /page/0/Picture/3 description: The image contains two logos. The logo on the left is a square with rounded corners and contains the letters "UV" in a bold, sans-serif font. Below the letters, the text "ISO 9002" is visible, followed by some smaller text. The logo on the right is a square with rounded corners and contains the letter "C" in a bold, sans-serif font.
MAR 2 5 2003
: DR. SUPENO SURYA, MBA PhD (1) Name of applicant : PT. SHAMROCK Manufacturing Corp. Jl. Pemuda No. 11 Medan 20151 - Indonesia Phone No. : 62-61-4558888 : 62-61-4520588 Fax No. : Emmy Tjoeng Contact person in U.S.A : 909-591-8878 Fax No. (2) Device details Trade Name : Latex Examination Gloves Powder Free With Lined. C on thin as from a : Latex Examination Gloves Powder Free with Neoprene Classification Name Lined. (3) Product Code : 80 LYY
"510 (K)" SUMMARY
(4) Equivalent device legally marketed
: Class I Examination Gloves 80 LYY meeting ASTM D 3578-01ae2
- (5) Intended use
: Latex Examination Gloves Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
OFFICE :
JI. 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 the letters "SMC" in a bold, sans-serif font, superimposed over a four-leaf clover. The clover and letters are contained within a circle, which has a thick, dark outline. The image appears to be a black-and-white scan or photocopy, as there is some noise and imperfections throughout the image.
PT. Shamrock
Manufacturing
Corpora
Image /page/1/Picture/2 description: The image contains two logos side by side. The logo on the left has a triangle with the letters "TUV" above the words "Rheinland Product Safety". The logo on the right has the letters "GM" with a medical symbol in the middle. There is text below the letters "GM", but it is too small to read.
Image /page/1/Picture/3 description: The image contains two cropped images of signs. The sign on the left has a white background with a black border. There is a black drawing of a planet with rings on the sign. The sign on the right has a white background with a black border. The sign has a large, bold, black letter C on it.
K030134
(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 that the gloves meet or exceed the ASTM D 3578-01ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.
OFFICE :
OFFICE: 0151 - indonesia Phono (62-61) : smc@shamrock-id.com
FACTORY : ·
Jl. Raya Medan - Namorambe Ps. IV Kab. Deli Seriang Phone (62-61) 703 0008 Fax. (62-61) 703 0007
Partis (62-61) 703 000 Bernet Bernikel (Giograch(Giograsat pel id E-mail : shamrock@indosat.net.id.
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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 features a stylized eagle with three lines forming its body and head. The words "HUMAN SERVICES • USA" and "DEPARTMENT OF" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2003
PT Shamrock Manufacturing Corporation C/O Ms. Emmy Tjoeng Marketing Director Shamrock Manufacturing Company 5445 Daniels Street Chino, California 91710
Re: K030134
Trade/Device Name: Latex Examination Gloves Powder Free with Neoprene Lined, Green 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 4, 2003 Received: March 3, 2003
Dear Ms. 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.
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Page 2 - Ms. Tjoeng
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 (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), please contact the Office of Compliance at (301) 594-4618. 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 Rurrer
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
Enclosure
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Image /page/4/Picture/0 description: The image is a black and white logo. The logo is a circle with a four-leaf clover inside. The letters "SMC" are written in white across the clover. The clover is black, and the circle is outlined in black.
PT. Shamrock Manufacturing
Image /page/4/Picture/2 description: The image shows four different certification logos. The first logo has a triangle above the text "TUV Rheinland Product Safety". The second logo has a medical symbol above the text "Approved medical device". The third logo has the text "TUV CERT DIN EN ISO 9002 Certificate 01 100 000971". The fourth logo has the letters "CE".
ANNEXURE II
INDICATION FOR USE
Applicant Device Name Indication for use : PT. SHAMROCK Manufacturing Corp. : Latex Examination Gloves Powder Free with Neoprene lined : Contains so migm or less of fotal water Extractatore Professo per gram
Latex Examination Glove Powder Free with Neoprene lined is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
(signature)
(signature)
DR.SUPENO SURYA, MBA PhD
(Type Name)
JAN 03. 2003
(date)
Qum S. Lin
Division Sign-Off) ivision of Anesthesiology, General H Infection Control. Dental Dental
510(k) Number: K030134