(36 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.
Private Label - Nitrile Examination Gloves Pre-Powdered, Blue and White Color
The provided document is a 510(k) submission for Nitrile Examination Gloves. It details the product, its intended use, and its technological characteristics and performance data compared to an equivalent device. However, it does not describe a study that uses AI or machine learning models or involves human readers and experts in the context of device performance evaluation.
Instead, the document focuses on the physical and performance attributes of the gloves, referencing ASTM standards and FDA requirements. Therefore, I cannot extract information related to AI performance, human reader studies, ground truth establishment, or sample sizes for AI training/testing from this document.
The acceptance criteria and reported device performance are related to the physical properties and dimensions of the Nitrile Examination Gloves as per ASTM D 3578-95 standards.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D 3578-95) | Reported Device Performance (Nitrile Exam Gloves) |
|---|---|---|
| Dimensions | ||
| Length (min) mm | Not explicitly stated as "criteria", but 240 mm is consistently reported. | 240 mm |
| Palm width mm | Not explicitly stated as "criteria", but ranges are consistently reported. | Small: 85 ± 10 mm Medium: 95 ± 10 mm Large: 111 ± 10 mm |
| Thickness (min) | ||
| 1. Cuff (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| 2. Palm (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| 3. Fingertip (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| Physical Properties (Before Aging) | Minimum values required by ASTM D 3578-95 | |
| Tensile Strength (min) | 14 Mpa | 14 Mpa |
| Ultimate Elongation (min) | 700 % (Small) 700 % (Medium) 700 % (Large) | 700 % (Small) 700 % (Medium) 500 % (Large) |
| Physical Properties (After Aging at 100° for 22 hrs) | Minimum values required by ASTM D 3578-95 | |
| Tensile Strength (min) | Not explicitly stated as "criteria", but 14 Mpa is consistently reported. | 14 Mpa |
| Ultimate Elongation (min) | Not explicitly stated as "criteria", but 500 % is reported for aged gloves. | 500 % |
| Inspection Related Defects | AQL (Acceptable Quality Level) | |
| Watertightness (Holes) | 2.5 (S-4) | Meets FDA pinholes requirement. |
| Dimension (Width, length, Thickness) | 4 (S-2) | Meets ASTM Standard. |
| Physical Properties (Before & After Aging) | 4 (S-2) | Meets ASTM Standard. |
| Weight of residual powder in medium size gloves: | 150 ± 50 mg | (Reported as a characteristic, no explicit criteria for passing) |
2. Sample size used for the test set and the data provenance:
- The document refers to "Inspection Related Defeats" with AQL (Acceptable Quality Level) values (e.g., S-4 for watertightness, S-2 for dimension and physical properties). These AQL values imply a sampling plan used for quality control, but the specific sample sizes for the test sets are not provided.
- The data provenance is for gloves manufactured by PT. EKA WIRA ASIA in Medan, Indonesia. The data is retrospective, as it describes the characteristics of the manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes performance testing of physical products (gloves) against established ASTM standards, not evaluation by human experts using a ground truth.
4. Adjudication method for the test set:
- This information is not applicable for the same reason as point 3. Testing is against objective physical standards.
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 information is not applicable as the document is about the physical properties of examination gloves, not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable as the document is about the physical properties of examination gloves.
7. The type of ground truth used:
- The "ground truth" for the device's performance is established by ASTM D 3578-95 standards and FDA requirements (e.g., pinholes requirement). These are objective, pre-defined specifications rather than expert consensus, pathology, or outcomes data in a medical diagnostic context.
8. The sample size for the training set:
- This information is not applicable. There is no mention of a "training set" as the device is a physical product (gloves) and not an AI/ML model.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
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Mar-13-98 12:02P G S I
APR - 2 1998
P.04
| K980729 | |
|---|---|
| -- | --------- |
| PT. EKA WIRA ASIA | |
|---|---|
| Jl. Haji Zainal Arifin 128 B-C | |
| Medan 20112 - Indonesia |
| Tel. 62-61-328888 (Hunting) | |
|---|---|
| 62-61-520688 (Direct) | |
| 62-61-730008 | |
| Fax. 62-61-520588 | |
| 62-61-730008 |
| Page Numbers 1 of 2 | |
|---|---|
| SUMMARY OF 510(K) SUBMISSION # K980729 | |
| (1) Name of applicant | : Mr. Hansen Laurence |
| Address | : PT. EKA WIRA ASIA |
| Jl. Haji Zainal Arifin 128 B-C | |
| Medan 20112 - Indonesia | |
| Phone No. | 62-61-328888; 62-61-730008 |
| Fax No. | 62-61-520588; 62-61-730007 |
The contact persons within the firm as well as in U.S.A. are given below:
| Contact person in firm | : Mr. Hansen Laurence |
|---|---|
| Fax No. | 62-61-520588; 62-61-730007 |
| Contact person in U.S.A. | : Emmy Tjoeng |
| Fax No. | 562-693-8866 |
| (2) Device details | |
|---|---|
| Trade Name | : Private Label - Nitrile Examination Gloves |
| Pre-Powdered, Blue and White Color | |
| Classification Name | : Patient Examination Gloves |
| Product Code | : Nitrile 80 LZA |
| (3) Equivalent device legally marketed | : Class I Nitrile Examination Gloves 80 LZA Pre-Powdered |
| meeting ASTM D 3578 - 95 | |
| (4) Intended use | : A patient examination glove is a disposable device intended |
| for medical purpose that is worn on examiner's hand or finger | |
| to prevent contamination between patient and examiners. |
2121
FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG
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Image /page/1/Picture/2 description: The image shows a black and white logo. The logo is circular and contains a figure standing with their legs apart and arms raised. Above the figure are several lines radiating outwards, resembling sun rays. There are also two horizontal lines on either side of the figure.
EKA WIRA ASIA
Jl. Haji Zainal Arifin 128 B-Medan 20112 - Indonesia
"|"click. 62-61 - 328888 (11. 62-61 - 520688 (1)ire 62-61 - 730008 ドはメ 62-61 - 520588 62-61 - 730008
Page Numbers 2 of 2
After Aging at 100° for 22 hrs
AQL
SUMMARY OF 510(K) SUBMISSION # K980729
- (5) Technological characteristic of the gloves.
- g. Dimensions
| SIZES | SMALL | MEDIUM | LARGE |
|---|---|---|---|
| Length (min) mmPalm width mmThickness | 240$85 \pm 10$ | 240$95 \pm 10$ | 240$111 \pm 10$ |
| 1. Cuff (min)2. Palm (min)3. Fingertip (min) | 0.10.10.1 | 0.10.10.1 | 0.10.10.1 |
- h. Physical Properties
| Tensile Strength | 14 Mpa | 14 Mpa |
|---|---|---|
| Ultimate Elongation (min) | 700 % | 500 % |
Before Aging
Performance Requirement i. Inspection Related defeats Characteristic Level
| Watertightness | Holes | S - 4 | 2.5 |
|---|---|---|---|
| Dimension | Width, lengthThickness | S - 2 | 4 |
| Physical Properties | Before & AfterAging | S-2 | 4 |
Weight of residual powder in medium size gloves: 150 ± 50 mg j.
| k. Bio-Compatibility (attached) | Annexure XI |
|---|---|
| l. Test Results as per ASTM D 3578 - 95 (attached) | Annexure V |
- (6) Performance data is the same as mentioned immediately above.
- (7) Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
- (8) Non-clinical data Gloves meet or exceed the ASTM Standard. Meet FDA pin holes requirement. Meet labeling claim.
FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 1998
PT. Eka Wira Asia ·C/O Ms. Emmy Tjoeng Official Correspondent for PT, Eka Wira Asia Glove Source, Incorporated 12110 East Slauson Avenue #3 Santa Fe Springs, California 90670
Re : K980729 Nitrile Examination Gloves - Powdered Blue Trade Name: and White Requlatory Class: I LZA Product Code: February 23, 1998 Dated: February 25, 1998 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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Tjoeng
the Act for devices under the Electronic Product Radiation Control provisions, 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Whitaker
Timo v A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/3 description: The image is a black and white logo. The logo features a stylized figure standing with legs apart and arms raised, resembling a person or abstract form. Above the figure, there are radiating lines that suggest sunlight or energy emanating from the figure. The figure and radiating lines are set against a backdrop of two curved shapes that create a sense of enclosure or containment.
EKA WIRA ASIA
Jl. Haii Zainal Arifin 128 B-C Medan 20112 - Indonesia
62-61 - 328888 (Illunling) . ان ا 62-61 - 520688 (1)recel) 62-61 - 73000x 62-61 - 520588 ドは、 62-61 - 730008
ANNEXURE II
INDICATION FOR USE
: Mr.Hansen Laurence Applicant
:
: K980729 510(k) Number
Device Name
: Nitrile Patient Examination Gloves - Powder . Blue and White Color
Indication for use
A patient examination glove is a disposable device intended for medical purpose that is wom on the examiner's hand or finger to prevent contamination between patient and examiners.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Division of Dontal, Infection Control,
and General Hospital Device
(Division Sign-Oif)
510(k) Number
OR
Over-The Counter-Use X
(Optional Format 1-2-96)
FACTORY : JL. RAYA MEDAN - NAMORAMBE PS. IV KAB. DELI SERDANG
4
§ 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.