LogoFDA 510(k) Search
K Number
K984610
Device Name
POWDER FREE NITRILE EXAMINATION GLOVES
Manufacturer
SHIVA MEDICARE LTD.
Date Cleared
1999-02-09

(42 days)

Product Code
LZA
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
More Information

80LZA

Not Found

No
The document describes a standard medical glove and contains no mention of AI or ML technology.

No
The device, Nitrile Examination Gloves, is intended to prevent contamination between the patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or cure any condition.

No
Explanation: The device, Nitrile Examination Gloves, is described as a disposable device worn on the hand to prevent contamination. Its intended use is not for diagnosing a condition or disease, but rather as a barrier. The performance studies focus on physical properties and safety (e.g., freedom from holes, biocompatibility), not diagnostic accuracy.

No

The device is a physical glove made of Nitrile Latex, not a software application. The description focuses on material properties and physical performance tests.

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 the patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
  • Device Description: It's described as a Class I Nitrile Examination Glove, which is a common medical device for protection, not for diagnosing conditions.
  • Performance Studies: The performance studies focus on physical properties like length, width, thickness, tensile strength, elongation, powder content, protein content, moisture content, and biocompatibility. These are relevant to the glove's function as a barrier and protective device, not to its ability to diagnose a condition.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

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.

Product codes

LZA

Device Description

Class I Nitrile Examination Gloves (Powder free) 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

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 powder free manufactured by Shiva Medicare Limited is given below.
Measured Parameters of Nitrile Examination gloves (Powder free) manufactured by Shiva Medicare Ltd.,

CharacteristicsSIZEValue
  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

PHYSICAL PROPERTIES

CHARACTERISTICSBefore AgeingAfter Ageing
Tensile Strength18-20 mpa16-18 mpa
Elongation at break %750-800%650-700%

INSPECTION LEVEL OF AQL:

CharacteristicsRelated defectsLevelAQL
Freedom from HolesHolesS41.5
DimensionWidth , Length Thickness.S24
Physical PropertyTensile Strength, Elongation at Break.S24

POWDER CONTENT : 1 +/- 1 mg per glove
PROTEIN CONTENT: 30 +/- 10 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATABILITY: Biologically Compatible.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Class I Nitrile Examination Gloves ( Powder free) 80LZA

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K984610

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.

  1. DEVICE TRADE NAME : NIL COMMON NAME : Nitrile Examination Glove (Powder free)

  2. 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.

  3. DESCRIPTION OF THE DEVICE :

Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.

  1. 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

1

7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

| Measured Parameters of Nitrile
Examination gloves (Powder free)
manufactured by Shiva Medicare Ltd., | | | ASTM D3578
Requirement for
Nitrile 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 |

PHY SICAL PROPERTIES

: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

BEFORE AGEINGAFTER AGEING
CHARACTERISTICSSML VALUE *ASTD 3578 REQUIREMENTSML VALUEASTD 3578 Requirement
Tensile Strength18 - 20 mpa14 mpa min16 - 18 mpa14 mpa min
Elongation at break %750 - 800%700% min650-700%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.

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

| Ambile States Address All All All Andrews Address A Mark All Andrews A
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CONSULTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTIO | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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PROTEIN CONTENT:

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CARLE CALCULAR LEBURULER
CARD COLORICAL COLLECTION COLLECTION
AM AN AR | 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 10
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11 11 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

MOISTURE CONTENT:

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 4 40 30 30 3
CLASS COLLECT COLLECTION COLLEGION COLLECTION OF

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A STATUS COLLECTION CONTRACTION
CALL COLL COURSE AND IN CANNO A CALL
A CONSULER COLLECTION
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------------------ |

BIOCOMPATABILITY:

| ------------
CONSULARIO COLLEGIAL CLAUDIO COLLEGIAL COLLEGION
Free of the program and the program and the program of

SMT
CI OVE | DECUREMENT
11-4.119 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| .
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H10 001C2

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STATE OF COLLECT OF CLEASE OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH AND THE CHARGE OF CHEARTH AND THE CHARGE OF CHEARTH AND THE CHARGE OF CHEARTH AND THE CHARGE OF CHEARTH | omnahible
And and a come of the production of the program and any |

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.

3

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 Nitrile
Examination gloves (Powder free)

manufactured by Shiva Medicare Ltd.,
CharacteristicsSIZEValue
1. LengthEX-S235-240 mm
S235-240 mm
M235-240 mm
L235-240 mm
2. WidthEX S70MM
S82 mm
M93 mm
L107 mm
3. ThicknessEX S0.10mm
S0.10mm
M0.10mm
L0.10mm

PHY SICAL PROPERTIES

CHARACTERISTICSBefore AgeingAfter Ageing
Tensile Strength18-20 mpa16-18 mpa
Elongation at break %750-800%650-700%

INSPECTION LEVEL OF AQL:

CharacteristicsRelated defectsLevelAQL
Freedom from
HolesHolesS41.5
DimensionWidth , Length
Thickness.S24
Physical
PropertyTensile
Strength,
Elongation at
Break.S24

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.

4

POWDER CONTENT : 1 +/- 1 mg per glove

PROTEIN CONTENT: 30 +/- 10 ppm

MOISTURE CONTENT: .0.8% max

BIOCOMPATABILITY: Biologically Compatible.

  1. 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.

5

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

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 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

7

3.0 INDICATIONS FOR USE:

APPLICANTSHIVA MEDICARE LIMITED
510(K) No.K984610
DEVICE NAMENITRILE 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