(413 days)
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. The device is for over-the counter single use.
The provided document is a 510(k) premarket notification for Sterile Latex Surgical Gloves, Powderfree. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or performance for an AI/ML-based device.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.
The document primarily addresses the following for medical devices like surgical gloves:
- Acceptance Criteria & Device Performance: This section is presented as a comparison table against the predicate device and relevant ASTM/ISO standards.
- Non-Clinical Testing: The study proves the device meets acceptance criteria through various standardized tests.
Here's the relevant information extracted from the document concerning the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Test Standard | Acceptance Criteria (from Standard) | Reported Device Performance (Sterile Latex Surgical Gloves, Powderfree) | Result |
|---|---|---|---|---|
| Freedom from Holes | ASTM D3577-09 / ASTM D5151-06 (Re-approved 2011) / FDA 1000ml water leak test | Sampling plan/Inspection level/AQL: ISO 2859-1 / G1/AQL 2.5 (for FDA 1000 ml water leak test) | PASS (for FDA 1000ml water leak test) | PASS |
| Dimensions: Length | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Overall length min 265 mm | > 265 mm | PASS |
| Dimensions: Width | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Varies from 76 mm for 6.0 size to 114 mm for 9.0 size (76±6 mm to 114±6 mm for sizes 6.0 to 9.0) | 76±6 mm to 114±6 mm (sizes 6.0 to 9.0) | PASS |
| Dimensions: Thickness | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Minimum 0.10mm (Cuff, palm & finger) | > 0.10 mm (Cuff, palm& finger) | PASS |
| Physical Properties: Before aging | ASTM D3577-09 and ASTM D412-06 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Tensile strength 24 Mpa min; Ultimate elongation 750% min | Tensile strength : > 24 Mpa ; Ultimate Elongation : >750% | PASS |
| Physical Properties: After Accelerated aging | ASTM D3577-09 and ASTM D573-04 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Tensile strength 18 Mpa min; Ultimate elongation 560 % min | Tensile strength : > 18 Mpa ; Ultimate Elongation : > 560% | PASS |
| Powder-free residue | ASTM D3577-09 and ASTM D6124-06 | Sampling plan: N=5 ; Less than 2 mg per glove | Less than 2 mg per glove | PASS |
| Biocompatibility: Primary skin irritation | ISO 10993-10 | Under the conditions of the study the device is not an irritant | Under the conditions of the study the device is not an irritant | PASS |
| Biocompatibility: Skin Sensitization | ISO 10993-10 | Under the conditions of the study the device is not a sensitizer | Under the conditions of the study the device is not a sensitizer | PASS |
| Sterility | ISO-11737-2 | Sterile | Sterile | PASS |
| EO Residue | ISO 10993-07:2008 | Maximum limit of EO Residue : 0.0025mg/device | Meets | Meets |
| ECH Residue | ISO 10993-07:2008 | Maximum limit of ECH Residue : 0.0025mg/device | Meets | Meets |
| Expiration dating/Shelf life | ASTM D7160-05 | Not explicitly stated in criteria table, but mentioned as "Three years" | Three years | Meets |
| Sterilization | ISO 11135-2014(E) | Requirements for the development, validation and routine control of a sterilization process for medical devices | Meets | Meets |
2. Sample size used for the test set and the data provenance
- Sample Sizes: Sample sizes are indicated within the "Sampling plan / Inspection level / AQL" columns in the performance data table (e.g., ISO 2859-1 / G1 / AQL 2.5, ISO 2859-1 / S2 / AQL 4.0, N=5 for powder-free residue). For the specific Freedom from Pinholes test, it notes: "Lot Size : 35001 – 150000 pair; Sample size : 200 pair".
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective" in the context of clinical studies, as this is laboratory/manufacturing performance data. The manufacturer is SANREA HEALTHCARE PRODUCTS PVT LTD, located in Palakkad, Kerala, India.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This type of testing involves laboratory and physical property measurements against established international standards (ASTM, ISO, FDA). "Ground truth" in this context is defined by the technical specifications and methodologies of these standards, not expert adjudication of medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As above, this pertains to physical and chemical testing against defined standard metrics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is a premarket notification for a Class I medical device (surgical gloves), not an AI/ML-based diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Standardized Test Methods and Specifications: The "ground truth" for the performance of these gloves is defined by the requirements and test methodologies outlined in the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM D3577-09 for rubber surgical gloves, ASTM D5151-06 for freedom from holes, ISO 10993 for biocompatibility, ISO 11135 for sterilization). The FDA 1000ml water leak test is also mentioned.
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable: There is no "training set" as this is not an AI/ML device.
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July 13, 2018
Sanrea Healthcare Products Pvt Ltd Jose M Manager QA & RA Plot #P-56, Pearl Road Kinfra IIT Park, Kanjikode Palakkad, 678 621 In
Re: K171550
Trade/Device Name: Sterile Latex Surgical Gloves, Powderfree Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: June 8, 2018 Received: June 12, 2018
Dear Jose 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.
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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); 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 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,
Elizabeth F. Claverie -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) K171550
Device Name
STERILE LATEX SURGICAL GLOVES, POWDER FREE
Indications for Use (Describe)
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
| 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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1.0 SUBMITTER
| 1.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD |
|---|---|---|
| 1.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial &Textile Park, Kanjikode, PalakkadKerala, India– 678 621 |
| 1.3 Telephone | : | + 91-491-2970145 |
| 1.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com,qa@sanrea.com |
| 1.5 Contact Person | : | Mr. JOSE PAUL MMANAGER 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 &Textile Park, Kanjikode, PalakkadKerala, India– 678 621 |
| 2.3 Telephone | : | + 91-491 -2970145 |
| 2.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com,qa@sanrea.com |
| 2.5 Contact Person | : | Mr. JOSE PAUL MMANAGER QA & RA |
| 3.0 PREPARATION DATE | : | 05TH July 2018 |
IDENTIFICATION OF THE SUBJECT DEVICE 4.0
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| 4.1 Device Name | : STERILE LATEX SURGICAL GLOVES, POWDER FREE |
|---|---|
| 4.2 Trade Name | : SANCARE STERILE LATEX SURGICAL GLOVES,GLOVTEK STERILE LATEX SURGICAL GLOVES |
| 4.3 Common Name | : SURGEON'S GLOVES |
| 4.4 Classification | : SURGEON'S GLOVES |
| 4.5 Class | : CLASS I |
| 4.6 CFR Regulation Number | : 21 CFR 878.4460 |
| 4.7 Product Code | : KGO |
5.0 IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE
| 5.1 Device Name | : | Powder free Sterile Latex Surgical Gloves, Yellow Color |
|---|---|---|
| 5.2 510(k) Number | : | K140988 |
| 5.3 Company | : | M/S. Hebei HongSen Plastic Technology Co. Ltd853 Dorchester Ln UnitbNew Milford, NJ 07646 |
| 5.4 Device Description | : | Powder free Sterile Latex Surgical Gloves, Yellow Color |
| 5.5 Classification | : | SURGEON'S GLOVES |
| 5.6 Class | : | CLASS I |
| 5.7 CFR Regulation Number | : | 21 CFR 878.4460 |
| 5.8 Product Code | : | KGO |
| 5.9 Classification Panel | : | General Hospital |
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DESCRIPTION OF THE DEVICE 6.0
The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. The device is for over-the counter single use.
7.0 INDICATIONS FOR USE
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber, intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
8.0 TECHNOLOGICAL CHARACTERISTICS COMPARISON
| Characteristics | PREDICATE - 510(K) :K140988 | SUBJECT DEVICE : | Comparison | |
|---|---|---|---|---|
| Manufacturer | M/S. Hebei HongSen PlasticTechnology Co. Ltd853 Dorchester Ln UnitbNew Milford, NJ 07646 | SANREA HEALTHCAREPRODUCTS PVT LTD. Plot # P-56, Pearl Road, Kinfra IntegratedIndustrial & Textile Park,Kanjikode, Palakkad, Kerala, India- 678 621 | - | |
| Product Name | Powder free Sterile LatexSurgical Gloves, Yellow Color | Sterile Latex Surgical Gloves,Powder free | Similar | |
| Intended Use | Intended to be worn byoperating room personnel toprotect a surgical wound fromcontamination. | Intended for medical purposesthat is worn by operating roompersonnel to protect a surgicalwound from contamination. | Same | |
| Indication foruse | The powder free sterile latexsurgical glove, yellow color(Brand Name: Titanfine), is adisposable device made of | The Sterile Latex SurgicalGloves, Powder free, is adisposable device made ofnatural rubber, intended for | Similar | |
| natural rubber intended to beworn by operating roompersonnel to protect a surgicalwound from contamination. | medical purposes that is worn byoperating room personnel toprotect a surgical wound fromcontamination. | |||
| Description | Sterile Powder free, surgicalgloves are made of naturalrubber latex. The gloves areprovided in Sizes 6.0, 6.5, 7.0,7.5, 8.0, 8.5 and 9.0 | Sterile Powder free , surgicalgloves are made of natural rubberlatex. The gloves are provided inSizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5and 9.0 | Same | |
| Presentation | Sterile gloves are provided inpouches | Sterile gloves are provided inpouches | Similar | |
| Material | Natural Rubber Latex | Natural Rubber Latex | Same | |
| Color | Yellow Color | Natural (No color is added) | Different | |
| Non-sterile orsterile | Sterile | Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Anatomic | Yes | Yes | Same | |
| Dimensions | Meets ASTM D3577-09 -Overall length min 265 mm,width varies from 76 mm for6.0 size to 114 mm for 9.0 size,thickness in cuff, finger andpalm has a minimum 0.10mm | Meets ASTM D3577 - 09Dimension for size 7.5 :Length : 300mmWidth : 95mmThickness - Cuff : 0.14mm, Palm :0.19mm, Finger : 0.22mm | Similar | |
| TensileStrength | Meets ASTM D3577 -09 andASTM D412, D573. Tensilestrength 24 Mpa min for beforeaging and 18 Mpa min for afteraging. Aging done at 70 $\pm$ 2 degC for 166 $\pm$ 2 hrs or 100 $\pm$ 2deg C | Meets ASTM D3577 -09 andASTM D412, D573.Results for size 7.5 :Tensile strength(Before Ageing): 31.22 MPaTensile strength | Similar | |
| for 22±0.3 hrs | (After Ageing): 24.43 MPa | |||
| UltimateElongation | Meets ASTM D 3577-09 -Ultimate elongation 750% minfor before aging and 560 % minfor after aging. Aging done at70 ±2 deg C for 166±2 hrs or100±2deg C for 22±0.3hrs | Meets ASTM D 3577-09 Resultsfor size 7.5 :Ultimate Elongation(Before Ageing) : 843.09 %Ultimate Elongation(After Ageing) : 762.28 % | Similar | |
| Freedom frompinholes | Meets ASTM D 5151 -06 andASTM D3577 – 09 | Meets ASTM D 5151 -06 (2011)and ASTM D3577- 09Results for size 7.5 :Inspection level/AQL :ISO 2859-1 / G1 / AQL 1.5Lot Size : 35001 – 150000 pairSample size : 200 pairHoles found : 0 holesAccept/Reject : 10/11 | Similar | |
| Residual PowderContent | Meets ASTM D 6124-06(2011) | Meets ASTM D 6124-06(2011)Result for size 7.5 :Powder content : 0.9mg/glove | Similar | |
| ResidualProtein Content | Meets ASTM D 5712 | Meets ASTM D 5712Result for size 7.5 :Protein Content : 25.56 µg/ dm2 | Similar | |
| BiocompatibilityTests -ISO 10993-10 | Under the conditions of thestudy the device is not anirritant | Under the conditions of the studythe device is not an irritant | Same | |
| Under the conditions of thestudy the device is not asensitizer | Under the conditions of the studythe device is not a sensitizer | Same | ||
| Sterility | Sterile | Sterile | Same | |
| Mode ofSterilization | Irradiation | EO Sterilization | Different | |
| Labeling | * Powder free* Latex Surgical Glove* Sterile* Single use only | * Powder free* Latex Surgical Glove* Sterile* Single use only | Identical |
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| * Anatomic | * Anatomic |
|---|---|
| * Manufactured for | * Manufactured for |
| * Lot No | * Lot No |
| * Intended use | * Intended use |
| * Quantity | * Quantity |
| * Country of origin | * Country of origin |
The above table shows similarities and differences of the performance between the subject device and the predicate device. There are only two minor differences between the subject device and the predicate device. One of the differences is that the predicate device has yellow color, while our device in submission is natural in color. The second difference is that the subject device is sterilized by EO sterilization where as the predicate device is sterilized by irradiation method. These minor differences do not impact the intended use, safety and performance of the device.
SUMMARY OF NON-CLINICAL TESTING 9.0
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 ofSterile Latex SurgicalGloves, Powder free |
|---|---|---|
| Freedom fromHoles | ASTM D3577-09 / ASTM D5151-06 | Meets |
| Dimensions | ASTM D3577-09 | Meets |
| Physical Properties | ASTM D3577-09 / ASTM D412-06 | Meets |
| Powder-freeresidue | ASTM D6124-06 | Meets |
| Bio-compatibility | Primary skin irritation - ISO 10993-10 | Non-irritant |
| Skin Sensitization - ISO 10993-10 | Non-sensitizer | |
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
| Sterilization | ISO 11135-2014(E) | Meets |
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| Sterilization of healthcare products - EthyleneOxide - Requirements for the development,validation and routine control of a sterilizationprocess for medical devices | ||
|---|---|---|
| ISO 10993-07:2008Biological evaluation of medical devices- Part 7:Ethylene oxide sterilization residualsMaximum limit of EO Residue :0.0025mg/device | Meets | |
| EO Residue | ||
| ISO 10993-07:2008Biological evaluation of medical devices- Part 7:Ethylene oxide sterilization residualsMaximum limit of ECH Residue :0.0025mg/device | Meets | |
| ECH Residue | ||
| ISO 11737 -2Sterilization of Medical devices-Microbiologicalmethods Part 2: Test of sterility performed in thedefinition , validation and maintenance ofsterilization process | Sterile | |
| Sterility |
Performance data of gloves based on ASTM D3577-09 and FDA 1000ml water leak test
| ASTM D3577 - 09 and FDA 1000 ml water leak test | |||||
|---|---|---|---|---|---|
| Characteristics | Test | Test standard | Sampling plan/Inspectionlevel / AQL | Sterile LatexSurgical Gloves,Powder free | Result |
| Freedom fromPin holes | FDA 1000 mlwater leaktest | ASTM D5151 -06(Re-approved 2011) | ISO 2859-1 /G1/AQL 2.5 | PASS | PASS |
| Length | ASTM D3577 -09 | ISO 2859-1 /S2/AQL 4.0 | > 265 mm | PASS |
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| Dimensions | Width | ASTM D3577-09 | ISO 2859-1 /S2/AQL 4.0 | 76±6 mm to 114±6mm (sizes 6.0 to 9.0) | PASS |
|---|---|---|---|---|---|
| Thickness | ASTM D3577-09 | ISO 2859-1 /S2/AQL 4.0 | > 0.10 mm(Cuff, palm&finger) | PASS | |
| Physicalproperties | Before aging | ASTM D3577-09and ASTM D412-06 | ISO 2859-1 /S2/AQL 4.0 | Tensile strength :> 24 Mpa | PASS |
| Ultimate Elongation: >750% | PASS | ||||
| AfterAcceleratedaging | ASTM D3577-09and ASTM D573-04 | ISO 2859-1 /S2/AQL 4.0 | Tensile strength :> 18 MpaUltimate Elongation: > 560% | PASS | |
| Powder-freeresidue | Powder-freeresidue | ASTM D3577-09 andASTM D6124-06 | N=5 | Less than 2 mg perglove | PASS |
| Biocompatibility | Primary skinirritation | ISO 10993 -10 | Under the conditions of the study thedevice is not an irritant | PASS | |
| SkinSensitization | ISO 10993 -10 | Under the conditions of the study thedevice is not a sensitizer | PASS | ||
| Sterility | Sterility | ISO-11737-2 | Sterile | PASS |
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.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).