(43 days)
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 …… '
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.
Powder Free - Latex Examination Gloves
The provided document, a 510(k) summary for PT. Shamrock Manufacturing Corporation's Powder Free - Latex Examination Gloves, describes the device and its performance data. However, it does not include detailed acceptance criteria or a study that specifically "proves" the device meets these criteria in the typical sense of a clinical or comparative effectiveness study for AI/medical imaging devices.
Instead, this document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Class I Examination Gloves 80 L YY meeting ASTM D 3578-99) by presenting performance data that meets established industry standards.
Here's an analysis based on the information provided, framed to address your requested points where applicable, and highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D 3578-99) | Reported Device Performance (Powder Free - Latex Examination Gloves) |
|---|---|---|
| Dimensions (Length mm min.) | 280 (for all sizes) | 280 (for Small, Medium, Large, X-Large) |
| Dimensions (Palm Width mm) | Small: 80±10, Medium: 95±10, Large: 111±10, X-Large: ≥ 110 | Small: 80±10, Medium: 95±10, Large: 111±10, X-Large: ≥ 110 |
| Thickness (Cuff mm min) | 0.20 | 0.20 |
| Thickness (Palm mm min) | 0.20 | 0.20 |
| Thickness (Finger Tip mm) | 0.20 | 0.20 |
| Tensile Strength (Before ageing) | : 21 Mpa (min) | : 21 Mpa (min) |
| Tensile Strength (After ageing at 70°C 168 hrs.) | : 18 Mpa (min) | : 18 Mpa (min) |
| Ultimate Elongation (Before ageing) | : 750 % (min.) | : 750 % (min.) |
| Ultimate Elongation (After ageing at 70°C 168 hrs.) | : 700 % (min.) | : 700 % (min.) |
| Pin Hole Requirement | Meets FDA pin hole requirement | Meets FDA pin hole requirement |
| Labeling Claim | Meets ASTM D 3578-99 | Meets labeling claim |
Explanation: The "acceptance criteria" for this device are the specifications outlined in the ASTM D 3578-99 standard and FDA pin hole requirements. The reported device performance matches these criteria exactly, as stated in section (6) "Technological characteristic of the gloves" and (9) "Non-clinical data."
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for testing these physical and performance characteristics. The testing methodology for ASTM standards would dictate this, but it is not elaborated upon in this 510(k) summary. The data provenance is not explicitly stated in terms of country of origin for the testing, but the manufacturer is PT. Shamrock Manufacturing Corporation in Indonesia. The testing would be considered retrospective as it likely occurred during product development and validation prior to this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable in the context of this device and document. "Ground truth" in the sense of expert consensus for medical imaging interpretations (like a radiologist reading an image) is not relevant here. The ground truth for glove performance is established by objective measurements against a recognized standard (ASTM D 3578-99).
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements among human readers or expert panels, typically in subjective assessment tasks. The testing of gloves involves objective measurements against a standard, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (latex examination gloves), not an AI diagnostic or assistive imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this device is based on objective measurements against established engineering and material science standards (ASTM D 3578-99) and regulatory requirements (FDA pin hole requirement). This is a form of performance standard ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning models, not for manufacturing specifications of gloves.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device. The standards (ASTM D 3578-99) were established through a consensus process by relevant industry and scientific bodies over time.
{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
| DimensionsSizes | Samll | Medium | Large | X-Large |
|---|---|---|---|---|
| Length mm (min.)PalmWidth mm | 28080±10 | 28095±10 | 280111±10 | 280≥ 110 |
| Thickness1. Cuff mm (min)2. Palm mm(min)3. Finger Tip mm | 0.200.200.20 | 0.200.200.20 | 0.200.200.20 | 0.200.200.20 |
| b. Physical Properties |
| Before ageing | After ageingat 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 .
§ 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.