(45 days)
Nitrile examination glove (Powder free) is a Powder free devices made of Nitrile Latex intent for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
The provided text describes the acceptance criteria and performance data for a Nitrile Examination Glove (Powder free) manufactured by Sri.Anusham Rubber Industries Pvt. Ltd. This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study design for an AI/Software as a Medical Device (SaMD). Therefore, many of the requested details, such as those related to AI/MRMC studies, ground truth establishment, and sample sizes for training/test sets, are not applicable or available in this document.
However, I can extract the acceptance criteria and reported device performance from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D3578 Requirement) | Reported Device Performance (SARI Value) |
|---|---|---|
| Length (EX-S) | 220 mm minimum | 235-240 mm |
| Length (S) | 220 mm minimum | 235-240 mm |
| Length (M) | 230 mm minimum | 235-240 mm |
| Length (L) | 230 mm minimum | 235-240 mm |
| Width (EX S) | 70 +/- 6 mm | 70 mm |
| Width (S) | 80 +/- 6 mm | 82 mm |
| Width (M) | 95 +/- 6 mm | 93 mm |
| Width (L) | 111 +/- 6 mm | 107 mm |
| Thickness (all sizes) | 0.08 mm minimum | 0.10 mm |
| Tensile Strength (Before Ageing) | 14 mpa min | 18 - 20 mpa |
| Elongation at break % (Before Ageing) | 700% min | 750 - 800% |
| Tensile Strength (After Ageing) | 14 mpa min | 16 - 18 mpa |
| Elongation at break % (After Ageing) | 500% min | 650 - 700% |
| Freedom from Holes (AQL) | 4 | 1.5 |
| Dimension (AQL) | 4 | 4 |
| Physical Property (AQL) | 4 | 4 |
| Powder Content | 2 mg/glove max | Nil Powder (later reported as 1 +/- 1 mg per glove) |
| Protein Content | Value not fixed | "Value not fixed" (later reported as 30 +/- 10 ppm) |
| Moisture Content | Value not fixed | 0.8% max |
| Biocompatibility | Biologically Compatible | Biologically Compatible |
Summary of Device Performance against Acceptance Criteria:
The "Conclusion of Performance Test Data" section explicitly states that the Nitrile Examination gloves manufactured by Sri. Anusham Rubber Industries Pvt. Ltd.:
- "Meet or exceed the ASTM D3578"
- "Meet FDA Pin hole Requirement."
- "Meet labelling claim as shown by the data"
Based on the tables above, the reported device performance values generally meet or exceed the specified ASTM D3578 requirements. For example, length, thickness, tensile strength, and elongation are all within or above the minimum requirements. Width values are also largely within the +/- 6mm tolerance. The AQL for "Freedom from Holes" (1.5) is better (lower AQL indicates better quality) than the ASTM requirement (4). Powder content is reported as "Nil Powder" initially, and then "1 +/- 1 mg per glove", both of which are within the "2 mg/glove max" requirement. Protein content and moisture content, for which ASTM requirements were "Value not fixed," have reported values. Biocompatibility is also stated to be compatible with FDA requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample size used for testing each characteristic. The "Level followed By SARI" for "Freedom from Holes," "Dimension," and "Physical Property" refers to inspection levels (S4, S2), which are part of a sampling plan (e.g., as per ISO 2859-1 or military standard 105E). These levels determine the severity of sampling, but not the absolute number of units tested.
- Data Provenance: The manufacturing company is M/s. SRI.ANUSHAM RUBBER INDUSTRIES PVT.LTD. in Tamil Nadu, India. The performance data is stated to be for gloves "manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD." This indicates the data is from tests performed on their products, likely at their facility or a contracted lab in India. The study is a prospective test of their manufactured products against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to the provided document. The "ground truth" here is defined by objective physical and chemical measurements governed by the ASTM D3578 standard, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As the "ground truth" is based on objective measurements against a standard, there is no expert adjudication process described.
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 section is not applicable. The device is a physical medical glove and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical glove and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for performance evaluation is based on objective measurements against an established international standard (ASTM D3578-95) for "Standard Specification for Rubber Examination Gloves." This standard defines acceptable physical properties, dimensions, and other characteristics.
8. The sample size for the training set
This section is not applicable. The document describes a physical product and its testing against a standard, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable. See point 8.
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PAGE NO- 57
510K SUMMARY as required by: 807.92( c ) 1.0.
:
2.0 APPLICANT
NAME
ADDRESS
M/s. SRI.ANUSHAM RUBBER INDUSTRIES PVT.LTD.
PIONEER MANIKANDAN BUILDINGS. VADASERY,NAGERCOIL, TAMIL NADU, INDID - 629001.
91-4652- 33091 / 32506 .
91-4652-32871
PH.NO.
FAX NO
CONTACT PERSON .. MR. N.PARAMASIVAN MANAGING DIRECTOR.
..
:
-
DEVICE TRADE NAME : NIL : Nitrile Examination Glove (Powder frec) COMMON NAME
-
Legally marketed device to which the company claiming equivalence: Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements ( ASTM D3578 - 95.
-
DESCRIPTION OF THE DEVICE :
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
- Intended use of the Device:
Nitrile examination glove (Powder free) is a Powder free devices made of Nitrile Latex intent for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Image /page/0/Picture/16 description: The image shows a circular stamp with the words "ANUSHAM RUBBER INDUSTR" and "NAGERCOIL" written on it. The text is arranged in a circular pattern around the center of the stamp. The stamp appears to be used, as the ink is not evenly distributed and there are some smudges.
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PAGE NO-58
7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.
| Measured Parameters of NitrileExamination gloves (Powder free)manufactured by Sri.Anusham Rubberindustries Pvt. Ltd., | ASTM D3578Requirement forNitrile Examinationglove (Powder free) | ||
|---|---|---|---|
| Characteristic | SIZE | Value | |
| 1. Length | EX-S | 235-240 mm | 220 mm minimum |
| S | 235-240 mm | 220 mm minimum | |
| M | 235-240 mm | 230 mm minimum | |
| L | 235-240 mm | 230mm minimum | |
| 2. Width | EX S | 70MM | 70 +/- 6 mm |
| S | 82 mm | 80 +/- 6 mm | |
| M | 93 mm | 95 +/- 6 mm | |
| L | 107 mm | 111+/- 6mm | |
| 3. Thickness | EX S | 0.10mm | 0.08 mm minimum |
| S | 0.10mm | 0.08 mm minimum | |
| M | 0.10mm | 0.08 mm minimum | |
| L | 0.10mm | 0.08 mm minimum |
PHYSICAL PROPERTIES
| BEFORE AGEING | AFTER AGEING | |||
|---|---|---|---|---|
| CHARACTERISTICS | SARI VALUE * | ASTD 3578REQUIREMENT | SARI VALUE | ASTD 3578Requirement |
| Tensile Strength | 18 - 20 mpa | 14 mpa min | 16 - 18 mpa | 14 mpa min |
| Elongation at break % | 750 - 800% | 700% min | 650-700% | 500% min |
SARI - SRI.ANUSHAM RUBBER INDUSTRIES .
WARM RUBBER INDUSTRIES PVT. LTD.
NAGERCOIL
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PAGE NO-59
PERFORMANCE REQUIREMENT
| Characteristics | Related defects | Level followedBy | AQLfollowed bySARI | AQL Value asper ASTMD3578. | |
|---|---|---|---|---|---|
| SARI | As perASTMD3578 | ||||
| Freedom fromHoles | Holes | S4 | S4 | 1.5 | 4 |
| Dimension | Width, LengthThickness. | S2 | S2 | 4 | 4 |
| PhysicalProperty | TensileStrength,Elongation atBreak. | S2 | S2 | 4 | 4 |
POWDER CONTENT
| SARI VALUE | ASTM REQUIREMENT |
|---|---|
| Nil Powder | 2 mg/glove max |
PROTEIN CONTENT:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | · REQUIREMENT |
|---|---|
| CADI VALUE | 1 |
| יי החם10 pom 11 | Value not fixed |
MOISTURE CONTENT:
| SARI VALIE | REOLITREMENT |
|---|---|
| of Cattle.0.8% .max | valle tixed.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
BIOCOMPATABILITY:
| SARI GLOVE | FDA REQUIREMENT |
|---|---|
| Biologically Compatible | Biologically Compatible |
Image /page/2/Picture/11 description: The image shows a circular stamp with the text "PUSHAM RUBBER INDUSTR S PVT LTD" around the border. In the center of the stamp, the text "NAGERCOIL" is written in a slightly tilted manner. The stamp appears to be somewhat faded or worn, giving it a vintage or used look.
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8.0 Performance Data:
The performance test data of the Nitrile Examination Glove powder free manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD. is given below.
| Characteristics | SIZE | Value |
|---|---|---|
| 1. Length | EX-S | 235-240 mm |
| S | 235-240 mm | |
| M | 235-240 mm | |
| L | 235-240 mm | |
| 2. Width | EX S | 70MM |
| S | 82 mm | |
| M | 93 mm | |
| L | 107 mm | |
| 3. Thickness | EX S | 0.10mm |
| S | 0.10mm | |
| M | 0.10mm | |
| L | 0.10mm |
PHY SICAL PROPERTIES
| CHARACTERISTICS | Before Ageing | After Ageing |
|---|---|---|
| Tensile Strength | 18 - 20 mpa | 16 - 18 mpa |
| Elongation at break % | 750 - 800% | 650-700% |
INSPECTION LEVEL OF AQL:
| Characteristics | Related defects | Level | AQL |
|---|---|---|---|
| Freedom fromHoles | Holes | S4 | 1.5 |
| Dimension | Width , LengthThickness. | S2 | 4 |
| PhysicalProperty | TensileStrength,Elongation atBreak. | S2 | 4 |
RUBBER INDUSTRY
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POWDER CONTENT : 1 +/- 1 mg per glove
PROTEIN CONTENT: 30 +/- 10 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATABILITY: Biologically Compatible.
NA 9. Clinical Data :
7. CONCLUSION OF PERFORMANCE TEST DATA:
The Nitrile Examination gloves Powder free manufactured by SRI. ANUSHAM RUBBER INDUSTRIES PVT.LTD.
- Meet or exceed the ASTM D3578 -
- Meet FDA Pin hole Requirement. .
- Meet labelling claim as shown by the data in 6 *
8. ANY OTHER INFORMATION:
Any other information required by FDA regarding product safety and effectiveness will be provided on request.
Image /page/4/Picture/13 description: The image is a circular stamp with text around the perimeter and in the center. The text around the perimeter reads "SRI ANUSHAM RUBBER INDUSTRIES PVT. LTD.". The text in the center reads "NAGERCOIL". There is a star symbol on the bottom left of the stamp.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Mr. N. Paramasivan Managing Director SRI Anusham Rubber Industries Private, Limited Pioneer Manikandan Buildings Vadasery, Nagercoil-629001 Tamil Nadu, S. India
K993348 Re : Nitrile Examination Glove-Powder Free Trade Name: Requlatory Class: I Product Code: LZA September 28, 1999 Dated: Received: October 5, 1999
Dear Mr. Paramasivan:
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, qood 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) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Paramasivan
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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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PAGE NO :3
3.0 INDICATIONS FOR USE:
| APPLICANT | : SRI.ANUSHAM RUBBER INDUSTRIES PVT.LTD. |
|---|---|
| 510(K) No. | : K 993348 |
| DEVICE NAME | : NITRILE EXAMINATION GLOVES POWDER FREE |
INDICATIONS FOR USE:
Nitrile Examination Gloves Powder free is a powder free disposable device made of Nitrile Latex intended for medical purpose, that is worn on the examiners hand or finger to prevent contamination between patient and Examiner.
Image /page/7/Picture/5 description: The image shows a circular stamp with the text "M. SHAM RUBBER INDUSTRIES PVT. LTD." around the outer edge. In the center of the stamp, the word "NAGERCOIL" is printed in a slightly curved manner. The stamp appears to be somewhat faded or worn, giving it a vintage or used look.
Evin S. Lin
(Division Sign-Off) ് അമേന of Dental, Infection Control, and Ceneral Hospital Dey 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.