(50 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary focuses on material properties and performance standards, with no mention of AI or ML.
No.
The device is an examination glove intended to prevent contamination, not to treat or alleviate a disease or condition.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose any condition. Its performance metrics relate to physical properties and quality control of the glove itself, not to diagnostic accuracy.
No
The device is a physical examination glove made of Nitrile Latex, which is a hardware component, not software. The description and performance studies focus on physical properties and testing of the glove material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's described as a Class I Patient Examination Glove. Examination gloves are generally considered medical devices, but not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, elongation, freedom from holes, etc.), which are relevant to its function as a barrier, not its diagnostic capability.
IVDs are devices intended to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Nitrile Examination Glove is a 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all 'the requirements of ASTM D3578- 95.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purpose
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data of the Nitrile examination glove manufactured by Shiva Medicare Limited is given:
- Characteristics (Length, Width, Thickness) for sizes EX-S, S, M, L.
- Physical Properties (Tensile Strength, Elongation at break %) before and after ageing.
- Inspection Level of AQL: Characteristics (Freedom from Holes, Dimension, Physical Property) with related defects, level, and AQL values.
- Powder Content: 120 +/- 20 mg per glove
- Protein Content: 30 +/- 10 ppm
- Moisture Content: 0.8% max
- Biocompatibility: Biologically Compatible.
The Examination gloves (Nitrile) manufactured by Shiva Medicare Limited:
- Meet or exceed the ASTM D3578.
- Meet FDA Pin hole Requirement.
- Meet labelling claim as shown by the data in 6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 1999
Shiva Medicare Ltd. C/O Mr. James F. Logan P.O. Box 3721 Crofton, Maryland 21114
Re : K984615 Powdered Nitrile Examination Gloves, Blue Trade Name: Regulatory Class: I Product Code: LZA November 12, 1998 Dated: Received: December 29, 1998
Dear Mr. Logan:
This letter corrects our substantially equivalent letter of November 12, 1998 regarding the error that was made on the address.
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, Druq, 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 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) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action.
1
Page 2 - Mr. Logan
In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Reqister. 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 labelinq 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 that 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 their toll free number (800) 638/2041 or at (301) 443-6597 or at its internet address
"http://www.fda.qov/cdrh/dsmamain.html".
in.html".
Sincerely
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
3.0 INDICATIONS FOR USE:
| APPLICANT | SHIVA MEDICARE LIMITED |
|---|---|
| 510(K) No. | K984615 |
| DEVICE NAME | NITRILE EXAMINATION GLOVES. Powdered, Blue |
INDICATIONS FOR USE:
DEVICE NAME
Nitrile Examination Glove is a 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
510(k) Number
Over-The-Counter Use X
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev
(Optional Format 1-2-96)
3
510K SUMMARY as required by: 807.92( c ) 1.0.
Image /page/3/Picture/1 description: The image shows a logo for "SHIVA". The logo consists of a black triangle with a stylized letter "S" inside it. The word "SHIVA" is written in bold, black letters below the triangle. The logo appears to be simple and modern.
| 2.0 APPLICANT | K984615 |
|---|---|
| NAME | M/s. SHIVA MEDICARE LIMITED |
|---|---|
| ADDRESS | A 15, 16, 17(PART) |
| MADRAS EXPORT PROCESSINGZONE | |
| KADAPERI, TAMBARAM, | |
| CHENNAI 600 045. | |
| INDIA. | |
| PH.NO. | 91-44-2368011/2368322/2362656/2362657 |
91-44-2368327 .. FAX NO
shivam@md2.vsnl.net.in : EMAIL
CONTACT PERSON : MR. SATISH JAIN EXECUTIVE DIRECTOR.
-
- DEVICE TRADE NAME : NIL Blue : Patient Examination Glove (Nitrile), Powdered COMMON NAME
-
Legally marketed device to which the company claiming equivalence: Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all the requirements of ASTM D3578 - 95.
-
DESCRIPTION OF THE DEVICE :
Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all 'the requirements of ASTM D3578- 95.
- Intended use of the Device:
Examination glove (Nitrile) is a 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/3/Picture/13 description: The image shows a black medical cross with the word "MEDICARE" diagonally across it. The cross is a simple design with thick, uniform lines. The word "MEDICARE" is in a sans-serif font and is also in black. The image appears to be a logo or symbol associated with Medicare.
Shiva 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: 5 hivani @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
4
7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.
| Measured Parameters of
Examination gloves (Nitrile)
manufactured by Shiva Medicare Ltd., | | | ASTM D3578
Requirement for
Examination glove
(Nitrile) |
|------------------------------------------------------------------------------------------------|------|------------|-----------------------------------------------------------------|
| 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 |
PHYSICAL 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
5
PERFORMANCE REQUIREMENT:
| Characteristics | Related defects | Level followed
By | | AQL
followed by
SML | AQL Value as
per ASTM
D3578. |
|-----------------------|-------------------------------------------------|----------------------|-------------------------|---------------------------|------------------------------------|
| | | SML | As per
ASTM
D3578 | | |
| Freedom from
Holes | Holes | S4 | S4 | 1.5 | 4 |
| Dimension | Width, Length
Thickness. | S2 | S2 | 4 | 4 |
| Physical
Property | Tensile
Strength,
Elongation at
Break. | S2 | S2 | 4 | 4 |
POWDER CONTENT
| SML VALUE | ASTM REQUIREMENT |
|---|---|
| 120 +/- 20 mg / glove | - |
PROTEIN CONTENT:
| -------------------
CART TO AT THE
AMAGA | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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6
8.0 --Performance Data:
The performance test data of the Nitrile examination glove manufactured by Shiva Medicare Limited is given below.
| Measured Parameters of | ||
|---|---|---|
| Examination gloves (Nitrile) | ||
| 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 from | |||
| Holes | Holes | S4 | 1.5 |
| Dimension | Width , Length | ||
| Thickness. | S2 | 4 | |
| Physical | |||
| Property | Tensile | ||
| Strength, | |||
| Elongation at | |||
| Break. | S2 | 4 |
7
POWDER CONTENT : 120 +/- 20 mg per glove
PROTEIN CONTENT: 30 +/- 10 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATABILITY: Biologically Compatible.
NA 9. Clinical Data :
CONCLUSION OF PERFORMANCE TEST DATA: 10.
The Examination gloves (Nitrile) manufactured by Shiva Medicare Limited
- Meet or exceed the ASTM D3578 -
- Meet FDA Pin hole Requirement. .
- Meet labelling claim as shown by the data in 6 -
11. ANY OTHER INFORMATION:
Any other information required by FDA regarding product safety and effectiveness will be provided on request.