SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
Device Facts
| Record ID | K171367 |
|---|---|
| Device Name | SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) |
| Applicant | Sanrea Healthcare Products Pvt, Ltd. |
| Product Code | LYY · General Hospital |
| Decision Date | Jan 26, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
Device Story
Sterile, powder-free, ambidextrous patient examination glove made of natural rubber latex; intended for single-use medical applications. Device acts as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Performance verified against ASTM D3578-05 standards for dimensions, physical properties, and freedom from holes. Sterilized via ethylene oxide (ISO 11135-2014). Biocompatibility confirmed per ISO 10993-10.
Clinical Evidence
Bench testing only. Performance data includes freedom from holes (ASTM D5151-06), dimensions, physical properties (tensile strength, elongation per ASTM D3578-05/D412-06), powder-free residue (ASTM D6124-06), residual protein (ASTM D5712-15), and biocompatibility (ISO 10993-10). Sterility validated per ISO 11737-2.
Technological Characteristics
Material: Natural rubber latex. Form factor: Ambidextrous, sterile, powder-free, sizes XS-XL. Standards: ASTM D3578-05, ASTM D5151-06, ASTM D412-06, ASTM D6124-06, ASTM D5712-15, ASTM D7160-05. Sterilization: Ethylene Oxide (ISO 11135-2014). Biocompatibility: ISO 10993-10.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand or finger to provide a barrier against contamination between patient and examiner.
Regulatory Classification
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.
Predicate Devices
- Powder free Latex Sterile Patient Examination Gloves (K052728)
Related Devices
- K153744 — A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) · A1 Glove Sdn Bhd · Aug 4, 2016
- K221185 — TC Gloves · Thanh Cong Pharmaceutical and Trading Company Limited · Jun 22, 2022
- K120692 — LATEX EXAMINATION GLOVES (POWDER FREE) · Top Calibre Sdn Bhd · May 14, 2012
- K021561 — DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O · Wrp Specialty Products Sdn. Bhd. · Jun 11, 2002
- K111133 — NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) · Ssc Surat Thani · Jun 24, 2011
Submission Summary (Full Text)
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January 26, 2018
Sanrea Healthcare Products Pvt Ltd Jose Paul M Manager QA & RA Plot#P-56, Pearl Road, Kinfra IIT Park, Kanjikode, Palakkad, 678 621, Kerala, IN
Re: K171367
Trade/Device Name: SANCARE STERILE LATEX EXAMINATION GLOVES Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYY Dated: December 26, 2017 Received: December 28, 2017
Dear Jose Paul M:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K171367
### Device Name SANCARE STERILE LATEX EXAMINATION GLOVES
### Indications for Use (Describe)
The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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### K171367
## 1.0 SUBMITTER
| 1.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD |
|--------------------|---|----------------------------------------------------------------------------------------------------------------------|
| 1.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial &<br>Textile Park, Kanjikode, Palakkad<br>Kerala, India– 678 621 |
| 1.3 Telephone | : | + 91-491-2970145 |
| 1.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com,<br>qa@sanrea.com |
| 1.5 Contact Person | : | Mr. JOSE PAUL M<br>MANAGER QA & RA |
## 2.0 OFFICIAL CORRESPONDENT
| 2.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD |
|--------------------|---|----------------------------------------------------------------------------------------------------------------------|
| 2.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial &<br>Textile Park, Kanjikode, Palakkad<br>Kerala, India– 678 621 |
| 2.3 Telephone | : | + 91-491 -2970145 |
| 2.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com,<br>qa@sanrea.com |
| 2.5 Contact Person | : | Mr. JOSE PAUL M<br>MANAGER QA & RA |
### 3.0 PREPARATION DATE :
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#### 4.0 NAME OF THE DEVICE
| 4.1 Device Name | : | STERILE LATEX PATIENT EXAMINATION<br>GLOVES, POWDER FREE |
|--------------------|---|---------------------------------------------------------------------------------------------------------|
| 4.2 Trade Name | : | SANCARE STERILE LATEX EXAMINATION GLOVES (also<br>marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) |
| 4.3 Common Name | : | PATIENT EXAMINATION GLOVES |
| 4.4 Classification | : | PATIENT EXAMINATION GLOVES |
| 4.5 Class | : | CLASS I |
| 4.6 Product Code | : | LYY |
### IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE 5.0
| 5.1 Device Name | : | Powder free Latex Sterile Patient Examination Gloves |
|--------------------------|---|-------------------------------------------------------------------------------------------------------|
| 5.2 510(k) Number | : | K052728 |
| 5.3 Company | : | M/S. KANAM LATEX INDUSTRIES PVT. LTD.<br>Ooppoottil Buildings, K.K. Road,<br>Kottayam, Kerala, 686001 |
| 5.4 Device Description | : | Powder free Latex Sterile Patient Examination Gloves |
| 5.5 Classification | : | PATIENT EXAMINATION GLOVES |
| 5.6 Class | : | CLASS I |
| 5.7 Product Code | : | LYY |
| 5.8 Classification Panel | : | General Hospital |
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#### 6.0 DESCRIPTION OF THE DEVICE
The subject device is a patient examination glove made of latex compound. It is sterile, Powder Free. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D3578-05: Standard specification for Rubber Examination Gloves. The subject device is substantially equivalent to legally marketed Latex Examination Powder Free gloves identified as Product code LYY. The device is for over-the counter single use.
#### 7.0 INDICATIONS FOR USE
The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
### 8.0 SUMMARY OF PERFORMANCE DATA
There is no difference in technological characteristics compared to the predicate device. Gloves are made from Latex compound, which is Sterile and Powder Free. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,
| Characteristics | Standards | Performance of Latex<br>patient examination<br>gloves, Powder Free |
|---------------------|-----------------------------------------|--------------------------------------------------------------------|
| Freedom from Holes | ASTM D3578-05/ ASTM D5151-06 | Meets |
| Dimensions | ASTM D3578-05 | Meets |
| Physical Properties | ASTM D3578-05/ ASTM D412-06 | Meets |
| Powder-free residue | ASTM D3578-05/ ASTM D6124-06 | Meets |
| Residual Protein | ASTM D3578-05/ ASTM D5712-15 | Meets |
| Bio-compatibility | Primary skin irritation<br>ISO 10993-10 | Non-irritant |
| | Skin Sensitization | Non-sensitizer |
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| | ISO 10993-10 | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
| Sterilization | ISO 11135-2014(E)<br>Sterilization of healthcare products -<br>Ethylene Oxide - Requirements for<br>the development, validation and<br>routine control of a sterilization<br>process for medical devices | Meets |
| Sterility | ISO 11737 -2<br>Sterilization of Medical devices-<br>Microbiological methods Part 2:<br>Test of sterility performed in the<br>definition, validation and<br>maintenance of sterilization process | Sterile |
### Performance data of gloves based on ASTM D3578-05and FDA 1000ml water leak test
Г
| ASTM D3578-05and FDA 1000 ml water leak test | | | | | |
|----------------------------------------------|-----------------------------------|--------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------|--------|
| Characteristics | Test | Test standard | Sampling<br>plan /<br>Inspection<br>level / AQL | Sterile, Powder Free,<br>Latex Patient<br>Examination Gloves-<br>Sancare / Glovtek | Result |
| Freedom from<br>Pin holes | FDA 1000<br>ml water<br>leak test | ASTM D5151 -06<br>(Re-approved 2011) | ISO 2859-1 /<br>G1/AQL 2.5 | PASS | PASS |
| Dimensions | Length | ASTM D3578-05 | ISO 2859-1 /<br>S2/AQL 4.0 | > 230 mm | PASS |
| | Width | ASTM D3578-05 | ISO 2859-1 /<br>S2/AQL 4.0 | 70±10 mm to 120±10<br>mm<br>(sizes XS to XL) | PASS |
| | | ASTM D3578-05 | ISO 2859-1 / | > 0.08 mm | PASS |
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| | Thickness | | S2/AQL 4.0 | (Cuff, palm& finger) | |
|------------------------|-------------------------------|---------------------------------------|----------------------------|---------------------------------------------------------------------|------|
| Physical<br>properties | Before<br>aging | ASTM D3578-05and<br>ASTM D412-06 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile strength :<br>> 18 Mpa | PASS |
| | | | | Ultimate Elongation :<br>>650% | PASS |
| | | | | Stress at 500%<br>elongation :<br>5.5 Mpa max | PASS |
| | | | | | |
| | After<br>Accelerated<br>aging | ASTM D3578-05and<br>ASTM D573-04 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile strength :<br>> 14 Mpa | PASS |
| | | | | Ultimate Elongation :<br>> 500% | PASS |
| | | | | | |
| | | | | | |
| | | | | | |
| Powder-free<br>residue | Powder-free<br>residue | ASTM D3578-05and<br>ASTM D6124-06 | N=5 | Less than 2 mg per<br>glove | PASS |
| Residual Protein | Residual<br>Protein | ASTM D3578-05 and<br>ASTM D 5712 – 15 | N=3 | Residual Protein : Less<br>than 50µg/dm² | PASS |
| Biocompatibility | Primary skin<br>irritation | ISO 10993 -10 | | Under the conditions of the study the<br>device is not an irritant | PASS |
| | | | | | |
| | Skin<br>Sensitization | ISO 10993 -10 | | Under the conditions of the study the<br>device is not a sensitizer | PASS |
| | | | | | |
| Sterility | Sterility | ISO-11737-2 | | Sterile | PASS |
| | | | | | |
### 9.0 Predicate Comparison Chart
| Characteristics | PREDICATE – 510(K) : | SUBJECT DEVICE : | Comparison |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | K052728 | | |
| Manufacturer | M/S. KANAM LATEX<br>INDUSTRIES PVT. LTD.<br>Ooppoottil Buildings,<br>K.K. Road,<br>Kottayam, Kerala, 686001 | SANREA HEALTHCARE<br>PRODUCTS PVT LTD. Plot #<br>P-56, Pearl Road, Kinfra<br>Integrated Industrial & Textile<br>Park, Kanjikode, Palakkad,<br>Kerala, India – 678 621 | - |
| Product Name | Powder free Latex Sterile<br>Patient Examination Gloves | Sterile Latex Patient<br>Examination Gloves, Powder<br>Free | Similar |
| | | | |
| Intended Use | Intended for medical purpose | Intended for medical purpose | Similar |
| | that is worn on the Examiners | that is worn on the | |
| | hand or finger to prevent | Examiners hand or finger to | |
| | contamination between | prevent contamination | |
| | patient and examiner | between patient and | |
| | | examiner | |
| Indication for | A Powder Free Patient | The Sterile Latex Patient | Similar |
| use | Examination Glove is a | Examination gloves, Powder | |
| | Disposable Device made of | Free is a disposable device | |
| | Natural Rubber Latex and is | intended for medical | |
| | intended to be worn on the | purposes that is worn on the | |
| | hands, for medical purposes | examiners hand or finger to | |
| | to provide a barrier against | prevent contamination | |
| | potentially infectious | between patient and | |
| | materials and other | examiner | |
| | contaminants. | | |
| Description | Sterile Powder Free, Patient | Sterile Powder Free, Patient | Similar |
| | Examination gloves made of | Examination gloves made of | |
| | natural rubber latex. The | natural rubber latex. The | |
| | gloves are provided in Sizes | gloves are provided in Sizes | |
| | Extra Small, Small, Medium, | Extra Small, Small, Medium, | |
| | Large and Extra Large | Large and Extra Large | |
| Presentation | Sterile gloves are provided in | Sterile gloves are provided in | Identical |
| | pouches | pouches | |
| Material | Natural Rubber Latex | Natural Rubber Latex | Identical |
| Product code | LYY | LYY | Identical |
| Non-sterile or | Sterile | Sterile | Identical |
| sterile | | | |
| Single Use | Yes | Yes | Identical |
| Ambidextrous | Yes | Yes | Identical |
| | Meets ASTM D3578 | Meets ASTMD3578 - | Identical |
| | | Overall length min 230 mm, | |
| Dimensions | | width varies from 70 mm for | |
| | | XS size to 120 mm for XL | |
| | | size, thickness in cuff, finger | |
| | | and palm has a minimum | |
| | | 0.08 mm | |
| | Meets ASTM D 3578and | Meets ASTM D 3578 and | Identical |
| | ASTM D412, D573 | ASTM D412, D573 - | |
| Tensile Strength | | Tensile strength 18 Mpa min | |
| | | for before aging and 14 Mpa | |
| | | min for after aging | |
| | | Aging done at 70 ±2 deg C | |
| | | for 166±2 hrs or 100±2deg C | |
| | | for 22±0.3 hrs | |
| | Meets ASTM D 3578 | Meets ASTM D 3578 | Identical |
| | | Ultimate elongation 650 % | |
| Ultimate | | min for before aging and 500 | |
| Elongation | | % min for after aging. Aging | |
| | | done at 70 ±2 deg C for | |
| | | 166±2 hrs or 100±2 deg C | |
| | | for 22±0.3 hrs | |
| Stress at 500% | Meets ASTM D 3578 | Meets ASTM D3578 - | Identical |
| Elongation | | Stress at 500% Elongation | |
| | | for before aging is 5.5Mpa<br>(max) | |
| Freedom from | Meets ASTM D 5151 and | Meets ASTM D 5151 and | Identical |
| pinholes | ASTM D3578 | ASTM D3578 | |
| | | Meets ASTM D 6124 | Identical |
| Residual Powder | Meets ASTM D 6124 | Less than 2 mg per glove | |
| Residual Protein | Meets ASTM D 5712 | Meets ASTM D 5712 –<br>Less than 50µg/dm² | Identical |
| Biocompatibility<br>Tests | Non-irritant –<br>Primary Skin Irritation In<br>Rabbits | Under the conditions of the<br>study the device is not an<br>irritant | Identical |
| ISO 10993-10 | Non-sensitizer –<br>Skin Sensitization in Guinea<br>pigs | Under the conditions of the<br>study the device is not a<br>sensitizer | Identical |
| Sterility | Ethylene Oxide sterilized | Ethylene Oxide sterilized | Identical |
| Labeling | * Powder Free<br>* Latex patient exam glove<br>* Sterile<br>* Single use only<br>* Ambidextrous<br>* Manufactured for<br>* Lot No<br>* Intended use<br>* Quantity<br>* Country of origin | *Powder Free<br>*Latex Patient exam glove<br>*Sterile<br>*Single use only<br>*Ambidextrous<br>*Manufactured for<br>*Lot No<br>*Intended use<br>*Quantity<br>*Country of origin | Identical |
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## 10.0 CONCLUSION
Based on the intended use, physical properties and technological characteristics, the subject device is as safe, as effective and performs as well as the legally marketed predicate device.
