(70 days)
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.
Latex Examination Gloves Powder Free With Lined.
The provided text describes a 510(k) premarket notification for "Latex Examination Gloves Powder Free With Lined." This submission is for a medical device that does not involve an AI component or complex analytical software. Therefore, the questions related to AI performance, ground truth, expert adjudication, and multi-reader multi-case studies are not applicable.
The document focuses on demonstrating that the gloves meet established industry standards for physical properties and safety.
Here's an analysis of the available information regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Minimum) | Reported Device Performance (Reference) |
|---|---|---|
| Dimensions | (ASTM D 3578-01ae2 Standard) | |
| Length mm (min.) | 220 (Small), 230 (Medium, Large, X-Large) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Palm Width mm | 80±10 (Small), 95±10 (Medium), 111±10 (Large), 120±10 (X-Large) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Thickness (min.) | ||
| - Cuff mm | 0.08 | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| - Palm mm | 0.08 | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| - Finger Tip mm | 0.08 | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Physical Properties | ||
| Tensile Strength | ||
| - Before ageing | 18 Mpa (min) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| - After ageing (70°C, 168 hrs) | 14 Mpa (min) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Ultimate Elongation | ||
| - Before ageing | 650 % (min.) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| - After ageing (70°C, 168 hrs) | 500 % (min.) | Met (Certify: "meets or exceed the ASTM D 3578-01ae2 Standard") |
| Safety/Quality | ||
| Pin Hole Requirement | FDA requirement | Met (Certify: "Meets FDA pin hole requirement") |
| Labeling Claim | Accuracy of labeling information | Met (Certify: "Meets labeling claim") |
| Total Water Extractable Protein | ≤ 50 micrograms per gram | Met (Stated in device name and indication for use) |
Notes:
- The document states that the performance data is "the same as mentioned immediately above," referring to the detailed table of dimensions and physical properties.
- The primary method of demonstrating acceptance is through a certification statement that the gloves meet or exceed the ASTM D 3578-01ae2 Standard and FDA pin hole requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing any specific batch or lot of gloves. It refers to the ASTM D 3578-01ae2 Standard for latex examination gloves, which would outline the sampling plan for such tests.
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: The manufacturer is PT. Shamrock Manufacturing Corp. located in Medan, Indonesia. The testing would have been conducted by them or a contracted laboratory to demonstrate compliance with the ASTM standard. The data is retrospective in the sense that it represents the characteristics of manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards) and regulatory requirements (e.g., FDA pinhole requirements). Testing is typically performed according to standardized protocols, and the results are compared against predefined criteria in these standards, not against expert consensus on individual "cases."
4. Adjudication Method for the Test Set
This question is not applicable. As explained above, for physical and chemical testing of gloves, results are typically objective measurements compared against specified quantitative criteria rather than subjective assessments 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
This question is not applicable. The device is a physical medical glove and does not involve AI or human readers for its intended use or evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical glove and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Industry Standards: Specifically, the ASTM D 3578-01ae2 Standard for Latex Examination Gloves. This standard defines the acceptable ranges for dimensions, tensile strength, and elongation, as well as test methods.
- Regulatory Requirements: The FDA pinhole requirement for medical gloves, which specifies an Acceptable Quality Level (AQL) for watertight integrity.
- Labeling Claims: Verification that the product meets its stated specifications, including the protein content claim ("Contains ≤ 50 micrograms or less of total water extractable protein per gram").
8. The Sample Size for the Training Set
This question is not applicable. As this is not an AI/ML device, there is no "training set." The manufacturing process is controlled to consistently produce gloves that meet the specified standards.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no "training set" for this type of device. The quality control and testing processes ensure that each batch of gloves (or a statistically significant sample from it) meets the established "ground truth" defined by the ASTM standard and FDA regulations.
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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.
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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.
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K030134
(6) Technological characteristic of the gloves.
| a. DimensionsSizes | 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 ageingat 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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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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PT. Shamrock Manufacturing
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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
§ 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.