(43 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 that would suggest the use of AI/ML.
No
The device is described as an examination glove intended to prevent contamination, not to treat a medical condition.
No
Explanation: The device described is an examination glove, which is used for prevention of contamination, not for diagnosing a condition or disease.
No
The device description clearly states it is a "Powder Free - Latex Examination Gloves," which is a physical hardware device.
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 glove worn on an examiner's hand to prevent contamination between the patient and examiner. This is a barrier device for personal protection and infection control.
- Device Description: The device is described as "Powder Free - Latex Examination Gloves." This aligns with the intended use as a physical barrier.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens for diagnostic purposes.
Therefore, the device described is a medical glove, not an IVD.
N/A
Intended Use / Indications for Use
A powder free examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination on examiner's hand: to prevent of ・・・・・・・・・・・・・・・
Powder free Latex Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Product codes
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
JUL 1: 7 2001
Image /page/0/Picture/1 description: The image shows a black and white logo with the letters "SVC" in a stylized font. The letters are arranged horizontally, with the "S" on the left, the "V" in the middle, and the "C" on the right. The logo is surrounded by a circular border. The image quality is somewhat degraded, with some pixelation and artifacts visible.
PT. SHAMROCK MANUFACTURING CORPORATION
Manufacturer of Latesx & Nitrillo Glovos.
Ji. Roya Bodas Namoramie PS, IV Kin 9
Jl. Roqa Média, Mapiripana P5, IV, Km. 2
Kab. Dell Seydang - Burnut - Indonesia
Tol: (62-01) 7030008 : Fax : (62-61) 7030007
Tel: (82-51)7451025 Fax : (82-51)7451027
DR. SUPENO SURYA, MBA, PAD
SHAMROCK Manufacturing Company
: 626-913-1498
: Powder Free - Latex Examination Gloves
: Powder Free - Latex Examination Gloves
J1. Raya Medan - Namorambe PS IV 31. Kaya Mosed
Kabupatén Deli Serdang - Indonesia
Phone No.
Fax No. : : 62-61-703-007
: Emmy Tjoeng
Fax No.
: 80 L Y Y
Page Numbers I of 2
"510 (K)" SUMMARY
K Olll.
( 1 ) Name of applicant Address
Contact person in U.S.A.
(2) Device details Trade Name
Classification Name
(3) Product Code
marketed
(4) Equivalent device legally
: : Class I Examination Gloves 80 L YY meeting ASTM D 3578-99
રક
1
Image /page/1/Picture/0 description: The image shows a circular emblem with the letters 'SNE' prominently displayed in the center. The letters are stylized and appear to be stacked on top of each other. The emblem has a textured border, and there is some additional design element, possibly a floral or leaf-like pattern, surrounding the letters. The overall image has a somewhat grainy or low-resolution quality.
PT. SHAMROCK MANUFACTURING CORPORATION
Manufacturer of Latex & Nitrile Gloves
JI. Raya Medan - Namorambe PS. IV Km. 9 Kab. Deli Sordang - Sumut - Indonesia Tel: {62-61} 7030008 ; Fax : (62-61) 7030007
Page Numbers 2 of 2
(5) Intended use
: A powder free examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination on examiner's hand: to prevent of ・・・・・・・・・・・・・・・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ー …… '
(6) Technological characteristic of the gloves.
Dimensions a
| Dimensions
| Sizes | Samll | Medium | Large | X-Large |
|---|---|---|---|---|
| Length mm (min.) | ||||
| PalmWidth mm | 280 | |||
| 80±10 | 280 | |||
| 95±10 | 280 | |||
| 111±10 | 280 | |||
| ≥ 110 | ||||
| Thickness |
- Cuff mm (min)
- Palm mm(min)
- Finger Tip mm | 0.20
0.20
0.20 | 0.20
0.20
0.20 | 0.20
0.20
0.20 | 0.20
0.20
0.20 |
| b. Physical Properties | | | | |
| | Before ageing | After ageing
at 70°C 168 hrs. |
|---------------------|----------------|----------------------------------|
| Tensile Strength | : 21 Mpa (min) | 18 Mpa (min) |
| Ultimate Elongation | : 750 % (min.) | 700 % (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
Gloves meet or exceed the ASTM D 3578-99 Standard. Meets FDA pin hole requirement. Meets labeling claim.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2001
PT. Shamrock Manufacturing Corporation C/O Ms. Emmy Tjoeng Official Correspondent Shamrock Manufacturing Incorporated 889 South Azusa Avenue City of Industry, California 91748
Re : K011712 Latex Examination Gloves- Powder Trade/Device Name: Free, Blue 880.6250 Regulation Number: Regulatory Class: I Product Code: LYY Dated: May 25, 2001 June 4, 2001 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. ਸੋ 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
3
Page 2 - Ms. Tjoeng
In addition, FDA may publish further announcements action. action. In addrerer, In the Federal Register. Please note: concerning your device in anket notification submission does this response to your premaint have under sections 531 not arrect any obrigation for devices under the Electronic Chrough 542 of the Act 101 xeviews, 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 described in your 510(x) premaince of your device to a legally Linding of Subscancial Cquiralits in a classification for your marketed predicate device robates in the to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regulacion (21 crk Fare 301 and se contact the Office of Villo draghostic deviced// promosonally, for questions on Compliance at (501) devertising of your device, please contact the Dromocron and advertibility of Journal (1301) Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97) . Other general premation on your responsibilities under the Act may be Information on your responsof Small Manufacturers Assistance oblained from the biributes (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas Wlodarski
Timo thy A. Ulatowski Director 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 is a black and white circular logo. The logo has the letters "SMC" in the center. The letters are stacked on top of each other. The background of the logo is a textured pattern. The border of the logo is a dotted line.
PT. SHAMROCK MANUFACTURING CORPORATION
Manufacturer of Latex & Nitrile Gloves
11 Rays Medan - Namorambo PS Kah, Dali Sordaina - Sumart - In Tel: (52-51) 7030008 ; Fax : (62-61) 70
ANNEXURE II
INDICATION FOR USE
Applicant Device Name Indication for use : Supeno Surya : Powder Free - Latex Examination Glov
Powder free Latex Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
(signature)
DR. Supeno Surya, MBA, PhD
(Type Name)
July 06, 2001
(date)
Oline S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .