(59 days)
A powder-free 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.
Powder-free Black Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
The provided text describes the performance testing and acceptance criteria for "Black Nitrile Examination Gloves, Powder Free, Non Sterile." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Requirement | Standard (Acceptance Criteria) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Physical Dimension | Length $\geq$ 230 mm Width = 95 + 10 mm Thickness $\geq$ 0.05 mm (Finger, Palm, Cuff) | Length = 240.9 mm Width = 97.7 mm Thickness: - Finger = 0.148 mm - Palm = 0.109 mm - Cuff = 0.092 mm | Yes |
| Physical Properties | Unaged: TS (Tensile Strength) = 14 MPa UE (Ultimate Elongation) = 500 % Aged: TS = 14 MPa UE = 400 % | Unaged: TS = 18.8 MPa UE = 679.4 % Aged: TS = 21.3 MPa UE = 767.4 % | Yes |
| Freedom from Pinholes | Acc / Rej = 3 / 4 (This likely refers to an AQL (Acceptable Quality Limit) level, implying a maximum number of accepted or rejected units per sample based on the standard) | Not explicitly stated in numerical terms, but the device is implied to have passed based on "Acc / Rej = 3 / 4" under STANDARDS. | Implied Yes |
| Moisture Content | 0.8% | 0.46% | Yes |
| Powder Residue | < 2.0 mg/glove | 0.96 mg/glove | Yes |
| Biocompatibility | Primary Skin Irritation in Rabbits: Pass Dermal Sensitization: Pass | Primary Skin Irritation in Rabbits: Pass (Negative) Dermal Sensitization: Pass (Negative) | Yes |
Note: The document also mentions other performance testing standards such as Water Leak Test (G-I, AQL 1.5), Visual Inspection (Critical AQL 0.65, Major AQL 2.5, Minor AQL 4.0), Residual Powder (N=5), and Moisture Content (N=8) in Section 5.0. However, the specific performance values for these tests are not detailed in Section 7.0 for the device.
2. Sample Size Used for the Test Set and the Data Provenance:
The document mentions sample sizes for some tests:
- Residual Powder: N = 5
- Moisture Content: N = 8
For other tests like water leak, physical dimension, physical properties, and visual inspection, AQL (Acceptable Quality Limit) levels (e.g., G-I, AQL 1.5; S-2, AQL 4.0; S-2, AQL 2.5) are specified. These AQLs are part of a sampling plan that determines the sample size and acceptance/rejection criteria based on the lot size, but the exact number of units tested for each batch is not explicitly stated as a single "sample size" in the provided text.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. The submitter is PT MAHAKARYA INTI BUANA, located in SUMUT – INDONESIA, implying the tests were conducted by or for them.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This is a medical device (gloves) and the "ground truth" for its performance is established by objective measurements against established engineering and safety standards (e.g., ASTM D 6319-00aE3, FDA 21 CFR 800.20), not by expert human consensus on image interpretation or similar.
4. Adjudication Method for the Test Set:
Not applicable. See point 3. Testing involves objective measurements, not human interpretation that requires adjudication.
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 not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (gloves), not an algorithm.
7. The type of ground truth used:
- Objective Measurements/Standards: The ground truth for performance claims is based on established international and national standards (e.g., ASTM D 6319-00aE3, FDA 21 CFR 800.20) for physical properties, dimensions, freedom from pinholes, moisture content, and powder residue.
- Biological Testing: Biocompatibility (Primary Skin Irritation and Dermal Sensitization) uses standardized laboratory animal tests (rabbits) to determine "Pass" or "Fail" based on observed biological responses.
8. The Sample Size for the Training Set:
Not applicable. This product does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. See point 8.
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K0904664
Image /page/0/Picture/1 description: The image shows a stylized, black and white graphic of the letters 'MB' in a gothic or old English font. The letters are large and bold, with intricate details and serifs characteristic of this type of font. The overall impression is one of formality and tradition.
.. - .
PT. MAHAKARYA INTI BUANA
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa – 20362
SUMUT – INDONESIA
Tel +62-61-30007150, 51, 52, 53
Fax +62-61-30007156
Date : February 10, 2009
510 (K) SUMMARY
APR 2 3 2009
| 1.0 | Submitter: | ||
|---|---|---|---|
| Name | PT MAHAKARYA INTI BUANA | ||
| Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18 | ||
| Tanjung Morawa – 20362 | |||
| SUMUT – INDONESIA | |||
| Phone No. | +62-61-30007150, 51 | ||
| Fax No. | +62-61-30007156 | ||
| FDA Registration No : | 3004049816 | ||
| 2.0 | Contact Person: | ||
| Name | (Mr) Azman Ismail | ||
| Phone | +62-61-30007150,51 | ||
| Fax No. | +62-61-30007156 | ||
| qa@mib-ia.com | |||
| 3.0 | Name of the device: | ||
| Trade Name | 1) Senstouch and | ||
| 2) Multiple or Customers' Trade Name | |||
| Device Name | Black Nitrile Examination Gloves, Powder Free, | ||
| Non Sterile | |||
| Common Name | Patient Examination Gloves | ||
| Classification Name | Nitrile Examination Gloves | ||
| 4.0 | Identification of The Legally Marketed Device: | ||
| Polymer | Nitrile Latex | ||
| Device Class | Class I | ||
| Substantial Equivalent | |||
| Device Description | Patient Examination Gloves, 21 CFR 880.6250 | ||
| Product Code | Nitrile - 80LZA | ||
| Standard | ASTM D 6319-00a (2005) | ||
| 5.0 | Performance Testing Standard: | ||
| Water Leak Test | G-I, AQL 1.5 | ||
| Physical Dimension | S-2, AQL 4.0 | ||
| Physical Properties | S-2, AQL 2.5, Single Sampling | ||
| Residual Powder | N = 5 | ||
| Moisture Content | N=8 | ||
| Visual Inspection | Critical Defects | AQL 0.65 | |
| Major Defects | AQL 2.5 | ||
| Minor Defects | AQL 4.0 | ||
Page 1 of 3
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Image /page/1/Picture/0 description: The image shows a stylized, gothic-style monogram consisting of the letters 'M' and 'B'. The letters are rendered in a bold, black color with intricate details and sharp edges, giving them a medieval or old-world appearance. The 'M' and 'B' are intertwined, creating a unified design that could be used as a logo or emblem. The overall impression is one of classic elegance and historical significance.
PT. MAHAKARYA INTI BUANA
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa -- 20362 SUMUT - INDONESIA
Tel +62-61- 30007150, 51, 52, 53 Fax +62-61-30007156
6.0 Intended Use of The Device
Powder-free Black Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
7.0 Summary of The Technological Characteristics of The Device (Performance and Conformance Test Data):
Technological characteristics of Black Nitrile Examination Gloves, Powder Free, Non Sterile are summarized as below:-
| REFERENCE | DEVICE | STANDARD | |
|---|---|---|---|
| REQUIREMENT | STANDARDS | PERFORMANCE | SPECIFICATION |
| Physical Dimension | D 6319-00aE3 | Length = 240.9 mmWidth = 97.7 mmThickness:- Finger = 0.148 mm- Palm = 0.109 mm- Cuff = 0.092 mm | Length $\geq$ 230 mmWidth = 95 + 10Thickness $\geq$ 0.05 |
| Physical Properties | D 6319-00aE3 | Unaged:TS = 18.8 MPaUE = 679.4 %Aged:TS = 21.3 MPaUE = 767.4 % | Unaged:TS = 14 MPaUE = 500 %Aged:TS = 14 MPaUE = 400 % |
| Freedom from Pinholes | D 6319-00aE3FDA 21 CFR800.20 | Acc / Rej = 3 / 4 | |
| Moisture Content | In-house | 0.46% | 0.8% |
| Powder Residue | D 6319-00aE3D6124 - 01 | 0.96 mg/glove | < 2.0 mg/glove |
| Biocompatibility | Primary SkinIrritation inRabbitsDermalSensitization | Pass(Negative)Pass(Negative) | PassPass |
Table 7.0 Performance and Conformance Data of Black Nitrile Examination Glove
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Image /page/2/Picture/0 description: The image shows a stylized monogram of the letters 'M' and 'B' in a gothic or blackletter style. The letters are rendered in black against a white background, with a textured or slightly distressed appearance. The 'M' and 'B' are intertwined or overlapping, creating a unified design.
PT. MAHAKARYA INTI BUANA
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa - 20362 SUMUT - INDONESIA
Tel +62-61-30007150,51,52,53 Fax +62-61-30007156
Substantial Equivalent Based on Assessment of Non-Clinical Performance 8.0 Data
The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
Based on the above data and information, the device is substantially equivalent to its predicate device approved for distribution in the United States. Part 4 of this submission discusses further on substantial equivalent comparison
Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0 Clinical data is not required for gloves for this submission.
10.0 Conclusion
It can be concluded that the Black Nitrile Powder Free Nitrile Black Examination Gloves, Non Sterile perform according to the gloves performance standards referenced in Section (5) and (7) above and hence meet ASTM standards and FDA requirements.
Conclusively, we therefore claim that this device is substantially equivalent to its predicate device approved by FDA and is safe and effective for its intended for purposes.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2009
Mr. Azman Ismail Quality Assurance Manager PT. MAHAKARYA INTI BUANA Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Number 18 Tanjung Morawa - 20362 SUMUT - INDONESIA
Re: K090464
Trade/Device Name: Black Nitrile Examination Gloves, Powderfree, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 13, 2009 Received: April 15, 2009
Dear Mr. Ismail:
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.
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
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Page 2- Mr. Ismail
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony D, on steam for
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology. General Hospital. 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): K 090464
Device Name: Black Nitrile Examination Gloves, Powderfree, Non-Sterile
Indications for use:
A powder-free 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.
Prescription Use
AND/OR
Over-The-Counter Use X
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) (Division Sign-Off) Division of Anton, Dental Devices
510(k) Number: K090464
Page 1 of 1
§ 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.