(18 days)
Not Found
Not Found
No
The device is a simple latex examination glove and the summary contains no mention of AI, ML, or any related computational technologies.
No.
The device (latex glove) is described as being worn to prevent contamination between patient and examiner, which indicates it is a protective barrier, not a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a latex examination glove, whose intended use is to prevent contamination between patient and examiner. It does not collect or analyze data to provide a medical diagnosis.
No
The device description and performance studies clearly indicate a physical product (latex examination gloves) with physical properties being tested, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description identifies it as a Class I Patient Examination Glove, which is a general medical device, not specifically an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The information provided focuses on the physical properties and performance of the glove as a barrier, which is consistent with a non-IVD medical device.
N/A
Intended Use / Indications for Use
Latex examination glove (Powder free) is a Powder free device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Latex Examination Gloves Powder free is a powder free disposable device intended i 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)
LYY
Device Description
Class I Patient Examination Gloves Latex ( Powder free) 80LYY 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
Not Found
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 powder free examination glove manufactured by Shiva Medicare Limited is given below.
Characteristics:
- Length: EX-S, S, M, L (235-240 mm for all sizes)
- Width: EX-S (70MM), S (82 mm), M (93 mm), L (107 mm)
- Thickness: EX-S, S, M, L (0.10mm for all sizes)
Physical Properties:
| CHARACTERISTICS | Before Ageing | After Ageing |
|---|---|---|
| Tensile Strength | 20 - 22 mpa | 18 - 20 mpa |
| Elongation at break % | 750-850% | 700-800% |
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 |
Powder Content: 1 +/- 1 mg per glove
Protein Content: 80 +/- 20 ppm
Moisture Content: 0.8% max
Biocompatibility: Biologically Compatible.
Conclusion of Performance Test Data:
The Powder free examination gloves 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
AUG | | 1998
Image /page/0/Picture/2 description: The image shows a logo with a stylized letter 'S' inside a triangle. The word 'SHIVA' is printed in bold, sans-serif font directly below the triangle. The logo is black and white.
510K SUMMARY as required by: 807.92( c ) 1.0.
| 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. |
| 3. DEVICE TRADE NAME
COMMON NAME | : NIL
: Patient Examination Glove (Powder free) |
Legally marketed device to which the company claiming equivalence: 4. Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all the requirements of ASTM D3578 - 95.
- DESCRIPTION OF THE DEVICE :
Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all 'the requirements of ASTM D3578- 95.
- Intended use of the Device:
Latex examination glove (Powder free) is a Powder free device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Image /page/0/Picture/11 description: The image shows the logo for Shiva Medicare Limited. The text "Shiva Medicare Limited" is written in a large, bold font. Below the company name, it says "100% Export Oriented Unit" in a smaller font. There is also a medical cross symbol on the left side of the image.
tered Office & Works : A 15-17. M.E.P.Z., Kadaperi, Tambaram, Chennai - 600 045 (INDIA) : 044/2368011/2368322 EMAIL: Shivan @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHVMEDI" orate Office : 808, Pragati Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA) nes : 011/5762314/5767046, Telex : 031-65886 SHIVA IN Fax 011-5751700
1
7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.
| Measured Parameters of Latex | ASTM D3578 | ||
|---|---|---|---|
| Examination gloves (Powder free) | Requirement for | ||
| manufactured by Shiva Medicare Ltd., | Latex Examination | ||
| glove (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 |
PHYSICAL PROPERTIES
| BEFORE AGEING | AFTER AGEING | |||
|---|---|---|---|---|
| CHARACTERISTICS | SML VALUE * | ASTD 3578 REQUIREMENT | SML VALUE | ASTD 3578 Requirement |
| Tensile Strength | 20 - 22 mpa | 14 mpa min | 18 - 20 mpa | 14 mpa min |
| Elongation at break % | 750 - 850% | 700% min | 700-800% | 500% min |
SML - SHIVA MEDICARE LIMITED
Image /page/1/Picture/5 description: The image shows a circular stamp with the text "SRIYA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras-600 045" is printed. The stamp appears to be black ink on a white background and is slightly faded, giving it a vintage or official document appearance.
2
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
| A A 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
No. or
TT I Y Y Y Y Y'T | - - DEAL IDEN TIDEN - -
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| and and a comments
S TH Y
numer
of control of the proport division, comprehensive, and the
No. of Cattle & F. Marsh of
Company and can and | 00170
And Annual Property of Children Annual Controller Company Company Company Comparis Comments of Children Comments of Children Comments of Children Comments of Children Comment |
PROTEIN CONTENT:
| www.banks.com/processories/article/ship/article/ship/spares/article/relation/relation/relation | REOUTREMENT | |
|---|---|---|
| SML VALUE | 1917 | |
| 00 | ||
| 00 | ||
| pom | ||
| 00 |
condidate dell'Annual | t
alue not fixed. | |
MOISTURE CONTENT:
| A should a free a marge of the many of the many of the many of the comments of the comments of
CAT ATT
A THE THE WATER
DIVI | Add About Administration
A Arranger program agains and control and the bases of the below the beginner of the company of the company of the company of the company of the company of the company of the
DEALTHENCEMENTT
1
1 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 0.8% max | t |
| www.balable.com/shares/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/ | valne |
| Supportunities Concession Company Company Company of the Artist of the Artists of the Artistics of the Artistics of the Article of the Article of | tixed |
| STATUTE OF THE PERSONAL PROPERTY OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHEARTH AND THE OFFICE AND THE OFFICE AND THE OFFICE OF CH | while and the first program and and decided dealers and any and and and of the commended to the commended |
| Comments of the count of the contract and any and any and any and any and | A Company Company Company Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Compares |
BIOCOMPATABILITY:
| SML GLOVE | FDA REQUIREMENT |
|---|---|
| Biologically Compatible | Biologically Compatible |
Image /page/2/Picture/10 description: The image shows a circular stamp with the text "SRIKA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras - 600 045." is printed. The stamp appears to be a low-resolution scan or photocopy, as the text and lines are somewhat blurred and pixelated.
3
Performance Data: 8.0
The performance test data of the powder free examination glove manufactured by Shiva Medicare Limited 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 | 20 - 22 mpa | 18 - 20 mpa |
| Elongation at break % | 750-850% | 700-800% |
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 |
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 visible. The stamp appears to be somewhat faded or of low resolution, giving it a worn or vintage look. The text is arranged in a way that follows the circular shape of the stamp.
4
POWDER CONTENT : 1 +/- 1 mg per glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATABILITY: Biologically Compatible.
NA 9. Clinical Data "
7. CONCLUSION OF PERFORMANCE TEST DATA:
The Powder free examination gloves manufactured by Shiva Medicare Limited
- Meet or exceed the ASTM D3578 ﺳﮯ
- 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/12 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 stamp.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | | 1998
M/s. Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 N Huntet Street Baltimore, Maryland 21202
Re: K982579 Latex Examination Gloves Powder-Free Trade Name: Requlatory Class: I Product Code: LYY Dated: July 24, 1998 Received: July 24, 1998
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, Druq, 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 aqainst misbrandinq 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, 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
6
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
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,
S. Dutman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
3.0 INDICATIONS FOR USE:
SHIVA MEDICARE LIMITED APPLICANT : K982579 : 510(K) No. LATEX EXAMINTION GLOVES POWDER FREE DEVICE NAME :
INDICATIONS FOR USE:
Latex Examination Gloves Powder free is a powder free disposable device intended i 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)
Clin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-9