(42 days)
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.
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
The provided documents describe a 510(k) submission for Nitrile Examination Gloves (Powder-free) manufactured by Shiva Medicare Limited, seeking to demonstrate substantial equivalence to a predicate device. This submission is for a Class I medical device, which typically does not involve complex AI algorithms or extensive clinical studies in the same way higher-risk devices might.
Based on the provided information, the acceptance criteria and study proving the device meets these criteria are focused on physical characteristics and performance of the examination gloves, aligning with ASTM D3578-95 standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D3578-95 Requirement) | Reported Device Performance (Shiva Medicare Ltd.) |
|---|---|---|
| Length (EX-S, S) | 220 mm minimum | 235-240 mm |
| Length (M, L) | 230mm 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 | 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 (SML) |
| Dimension (AQL) | 4 | 4 (SML) |
| Physical Property (AQL) | 4 | 4 (SML) |
| Powder Content | Not explicitly stated in ASTM D3578 section, but implied by "Powder-free" description. | 1 +/- 1 mg per glove |
| Protein Content | Not explicitly stated in ASTM D3578 section. | 30 +/- 10 ppm |
| Moisture Content | Not explicitly stated in ASTM D3578 section. | 0.8% max |
| Biocompatibility | Not explicitly stated in ASTM D3578 section. | Biologically Compatible |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific number of gloves tested for each characteristic. It refers to "Measured Parameters" and "Performance Data" but does not detail the statistical sampling plan (e.g., how many gloves from how many batches were tested). The AQL (Acceptable Quality Level) values (S4, S2) mentioned imply a standardized sampling plan used for quality control, but the exact sample sizes are not provided within this document.
- Data Provenance: The data is generated by the manufacturer, Shiva Medicare Limited, in India ("A 15, 16, 17(PART) MADRAS EXPORT PROCESSINGZONE KADAPERI, TAMBARAM, CHENNAI 600 045. INDIA."). The nature of the tests (physical and chemical properties) indicates that the data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective, measurable physical and chemical properties as defined by international standards (ASTM D3578-95). There is no "expert consensus" required for dimensions, tensile strength, or elongation at break; these are determined by laboratory measurements.
4. Adjudication Method for the Test Set:
This is not applicable. As stated above, the device performance is measured against objective, predetermined standards (ASTM D3578-95). There is no "adjudication" process in the sense of multiple human experts reviewing and deciding on a finding. The measurements either meet the specification or they don't.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is a physical product (examination gloves), not an AI-powered diagnostic device or an imaging product that would involve human readers interpreting cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This device is an examination glove, a physical product, not an algorithm or software. Therefore, standalone performance evaluation of an algorithm is not applicable.
7. The Type of Ground Truth Used:
The ground truth used is objective, measurable physical and chemical properties as defined by the ASTM D3578-95 international standard for rubber examination gloves. This standard sets the quantitative requirements for these properties.
8. The Sample Size for the Training Set:
Not applicable. This dossier describes a traditional medical device (gloves), not an AI/ML-based device. There is no "training set" in the context of machine learning. The "training" in manufacturing refers to process control and quality system implementation.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no AI/ML component, there is no "training set" or "ground truth for the training set" as defined in the context of AI. The product is manufactured and tested according to established quality control procedures against predefined standards.
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Image /page/0/Picture/2 description: The image shows a logo with a black triangle at the top and the word "SHIVA" in bold black letters below it. Inside the triangle, there is a stylized white letter "S" that is the focal point of the logo. The logo has a simple, clean design with a focus on the letter "S" and the name "SHIVA".
510K SUMMARY as required by: 807.92( c ) 1.0.
:
2.0 APPLICANT
NAME ADDRESS
M/s. SHIVA MEDICARE LIMITED A 15, 16, 17(PART) MADRAS EXPORT PROCESSINGZONE KADAPERI, TAMBARAM, CHENNAI 600 045. INDIA.
PH.NO. : 91-44-2368011/ 2368322/2362656/2362657. FAX NO : 91-44-2368327 EMAIL shivam@md2.vsnl.net.in : : CONTACT PERSON MR. SATISH JAIN EXECUTIVE DIRECTOR.
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DEVICE TRADE NAME : NIL COMMON NAME : Nitrile Examination Glove (Powder free)
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Legally marketed device to which the company claiming equivalence: Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578 - 95.
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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 intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Image /page/0/Picture/14 description: The image shows a circular stamp with the text "SHIVA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras-600 045" is present. A star symbol is located at the bottom of the circle. Below the stamp, the word "Shiva" is written in a larger, bold font.
iva Medicare Limited
(A 100% Export Oriented Unit)
Registered Office & Works : A 15-17, M.E.P.Z., Kadaperi, Tambaram, Chennai - 600 045 (INDIA) · Phones : 044/2368011/2368322 EMAIL: Shivam @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHIVMEDI" Corporate Office : 808, Pragati Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA) Phones : 011/5762314/5767046, Telex : 031-65886 SHIVA IN Fax 011-5751700
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7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.
| Measured Parameters of NitrileExamination gloves (Powder free)manufactured by Shiva Medicare Ltd., | ASTM D3578Requirement forNitrile Examinationglove (Powder free) | ||
|---|---|---|---|
| Characteristics | 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 |
PHY SICAL PROPERTIES
: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| BEFORE AGEING | AFTER AGEING | |||
|---|---|---|---|---|
| CHARACTERISTICS | SML VALUE * | ASTD 3578 REQUIREMENT | SML VALUE | ASTD 3578 Requirement |
| 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 |
SML – SHIVA MEDICARE LIMITED
Image /page/1/Picture/5 description: The image shows a circular stamp with the text "CHIVA MEDICARE LTD" around the outer edge. Inside the circle, the word "Madras" is printed in a smaller font. The stamp appears to be somewhat faded or worn, with some parts of the text and the circular border appearing incomplete. The overall impression is that of an official or company seal used on documents.
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PERFORMANCE REQUIREMENT:
| Characteristics | Related defects | Level followedBy | AQLfollowed bySML | AQL Value asper ASTMD3578. | |
|---|---|---|---|---|---|
| SML | 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
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|---|---|
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PROTEIN CONTENT:
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MOISTURE CONTENT:
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BIOCOMPATABILITY:
| ------------CONSULARIO COLLEGIAL CLAUDIO COLLEGIAL COLLEGIONFree of the program and the program and the program of-------------------------SMTCI OVE | DECUREMENT11-4.119 |
|---|---|
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Image /page/2/Picture/10 description: The image is a circular stamp with the text "SHIVA MIETCARE LTD." around the outer edge. Inside the circle, the text "Madras-600 045." is present. A five-pointed star is located at the bottom of the stamp. The stamp appears to be black and white.
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Performance Data: 8.0
The performance test data of the Nitrile Examination Glove powder free manufactured by Shiva Medicare Limited is given below.
| Measured Parameters of NitrileExamination gloves (Powder free)manufactured by Shiva Medicare Ltd., | ||
|---|---|---|
| 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 |
Image /page/3/Picture/7 description: The image shows a circular stamp with the text "SRIVA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras-600 045." is present. A five-pointed star is located at the bottom of the circle.
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POWDER CONTENT : 1 +/- 1 mg per glove
PROTEIN CONTENT: 30 +/- 10 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATABILITY: Biologically Compatible.
- Clinical Data NA :
7. CONCLUSION OF PERFORMANCE TEST DATA:
The Nitrile Examination gloves Powder free manufactured by Shiva Medicare Limited
- Meet or exceed the ASTM D3578 -
- Meet FDA Pin hole Requirement. ー
- r 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/12 description: The image is a black and white circular logo or seal. The text "SEIVA MEDICARE LTD." is arranged around the outer edge of the circle. Inside the circle, the text "Madras - 600 045." is displayed in the center.
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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1999
Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 North Hunter Street Baltimore, Maryland 21202
K984610 Re : Powder-Free Nitrile Examination Gloves, Blue Trade Name: Requlatory Class: I Product Code: LZA Dated: December 11, 1998 December 29, 1998 Received:
Dear Mr. Logan:
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 regulations 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 Failure to comply with the GMP verify such assumptions. requlation 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 - Mr. Logan
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 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 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,
K. Allard
Timathy A. 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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3.0 INDICATIONS FOR USE:
| APPLICANT | SHIVA MEDICARE LIMITED |
|---|---|
| 510(K) No. | K984610 |
| DEVICE NAME | NITRILE EXAMINATION GLOVES POWDER FREE, Blue |
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcc 21 CFR 801.109)
.
...
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 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.