(128 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.
Latex Examination Gloves Powder Free with Protein Claim
The provided text describes information related to a 510(k) submission for "Latex Examination Gloves Powder Free with Protein Claim" by PT. MAJA AGUNG LATEXINDO. While it details the device and its intended use, it does not explicitly contain a section titled "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format of a clinical study with detailed statistical results.
However, based on the provided text, the acceptance criteria for these gloves are primarily performance requirements and physical characteristics that are expected to meet certain standards, particularly ASTM D 3578-95 and FDA's pinhole requirement. The "study" proving these are met seems to be through non-clinical testing as specified in the document.
Here's an attempt to structure the available information into the requested format, inferring where explicit details are missing:
Acceptance Criteria and Device Performance Study (Inferred from 510(k) Submission)
The acceptance criteria for the Latex Examination Gloves Powder Free with Protein Claim are primarily based on established industry standards and regulatory requirements. The device's performance is demonstrated through non-clinical testing against these specified criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions (as per ASTM) | Length: min. 240 mm (all sizes) | Length: 240 mm (reported for S, M, L) |
| Palm Width Thickness: Small: 85±10 mm; Medium: 95±10 mm; Large: 111±10 mm | Palm Width Thickness: Small: 85±10 mm; Medium: 95±10 mm; Large: 111±10 mm | |
| Cuff Thickness: min. 0.10 mm | Cuff Thickness: 0.10 mm | |
| Palm Thickness: min. 0.10 mm | Palm Thickness: 0.10 mm | |
| Finger Tip Thickness: min. 0.10 mm | Finger Tip Thickness: 0.10 mm | |
| Physical Properties (as per ASTM) | Tensile Strength (Before Ageing): 21 MPa | Tensile Strength (Before Ageing): 21 Mpa |
| Tensile Strength (After Ageing at 70°C 168 hrs): 16 MPa | Tensile Strength (After Ageing at 70°C 168 hrs): 16 Mpa | |
| Ultimate Elongation (Before Ageing): min. 700 % | Ultimate Elongation (Before Ageing): 700 % (min.) | |
| Ultimate Elongation (After Ageing at 70°C 168 hrs): min. 600 % | Ultimate Elongation (After Ageing at 70°C 168 hrs): 600 % (min.) | |
| Performance Requirements | Watertight: Related Defects: Holes; Inspection Level: S-4; AQL: 2.5 | Meets FDA pin hole requirement |
| Dimensions: Related Defects: Width, Length & Thickness; Inspection Level: S-2; AQL: 4 | Meets specified dimensions | |
| Physical Properties: Related Defects: Before and after ageing; Inspection Level: S-2; AQL: 4 | Meets specified physical properties | |
| Chemical/Biological | Weight of residual powder (medium size gloves): 0.50 ± 0.20 mg | 0.50 ± 0.20 mg |
| Total water extractable protein: 50 microgram/gram (maximum) | 50 microgram/gram (maximum) | |
| Bio-Compatibility: | (Attached as Annexure XII) | |
| Standards Compliance | Meet ASTM D 3578-95 AQL requirements | Test Results as per ASTM D 3578-95 (Attached as Annexure V) |
| Meet FDA pin hole requirement | Meets FDA pin hole requirement | |
| Meets labeling claim | Meets labeling claim |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the testing of each criterion. However, it references ASTM D 3578-95 and inspection levels (S-4, S-2) with AQL values (2.5, 4) for performance requirements. These standards typically define the sampling plans and sample sizes for quality control and lot acceptance.
- Provenance: Non-clinical test data generated, likely by the manufacturer (PT. MAJA AGUNG LATEXINDO), in Indonesia. The data is retrospective in the context of this 510(k) submission, as it was generated prior to submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this context. The "ground truth" for the performance of the gloves is established by objective, standardized tests as per ASTM specifications and FDA requirements, not by expert consensus on subjective observations. The testing would have been conducted by trained laboratory personnel.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of interpretations (e.g., medical image reading). The results are quantitative measurements against predefined standards.
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 device is a medical glove, not an AI-assisted diagnostic or decision-support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The device itself is the glove, and its performance is assessed directly through physical and chemical testing.
7. The type of ground truth used
The "ground truth" is defined by objective, quantitative measurements and adherence to established industry standards (e.g., ASTM D 3578-95) and regulatory requirements (e.g., FDA pinhole requirement, protein content limits). This includes:
- Physical measurements (dimensions, tensile strength, elongation)
- Chemical analysis (residual powder, extractable protein)
- Integrity testing (watertightness/pinhole testing)
- Biological testing (biocompatibility, referenced as Annexure XII)
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "ground truth" for the device's performance is established by the accepted international and national standards it claims to meet.
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DEC 23 398
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K 982897 PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
62-61 - 859160 Telp. 62-61 - 859170 Fax. 62-61 - 859180
Page Numbers 1 of 2
"510 (K)" SUMMARY
| (1) Name of applicantAddress | : Mr. Hansen Laurence: PT. MAJA AGUNG LATEXINDOJl. H. Yamin No. 40 – 40 AMedan 20234IndonesiaPhone No.Fax No. | : 62-61-328888 ; 62-61-859170: 62-61-520588 ; 62-61-520588 |
|---|---|---|
| The contact persons within the firm as well as in U.S.A are given below: | ||
| Contact person in firm | : Mr. Hansen LaurenceFax No. | : 62-61-520588 ; 62-61-859170 |
| Contact person in U.S.A | : Emmy TjoengFax No. | : 562-693-8866 |
| (2) Device details | ||
| Trade Name | : Latex Examination GlovesPowder Free with Protein Claim | |
| Classification Name | : Patient Examination Gloves | |
| Product Code | : Latex 80 LYY | |
| (1) Equivalent device legallymarketed | : Class I Latex Examination Gloves 80 LYYPowder Free with Protein Claimmeeting ASTM D 3578 – 95 | |
| (4) Intended use | : A patient examination glove is a disposable deviceintended for medical purpose that is worn on examiner'shand or finger to prevent contamination between patientand examiners |
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Kg82897
Image /page/1/Picture/1 description: The image shows a logo with the letters "Ma" in a stylized font. The letters are black and appear to be handwritten or calligraphic. The background behind the letters consists of horizontal lines, creating a striped effect. The left side of the logo has a solid black shape, possibly a square or rectangle, that partially obscures the background lines.
PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
62-61 - 859160 Telp. 62-61 - 859170 Fax. 62-61 - 859180
Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
Page Numbers 2 of 2
| (5) Technological characteristic of the gloves. | ||||
|---|---|---|---|---|
| a. Dimensions | ||||
| Sizes | Small | Medium | Large | |
| Length (min.) | 240 mm | 240 mm | 240 mm | |
| Palm Width thickness | 85±10 mm | 95±10 mm | 111±10 mm | |
| 1. Cuff (min) | 0.10 mm | 0.10 mm | 0.10 mm | |
| 2. Palm (min) | 0.10 mm | 0.10 mm | 0.10 mm | |
| 3. Finger Tip (min) | 0.10 mm | 0.10 mm | 0.10 mm | |
| b. Physical Properties | ||||
| Before ageing | After ageing at 70°C 168 hrs. | |||
| Tensile Strength | : | 21 Mpa | 16 Mpa | |
| Ultimate Elongation | : | 700 % (min.) | 600 % (min.) | |
| c. Performance Requirement | ||||
| Characteristic | Related Defects | Inspection Level | AQL | |
| Watertight | Holes | S-4 | 2.5 | |
| Dimensions | Width Length & Thickness | S-2 | 4 | |
| Physical Properties | Before and after ageing | S-2 | 4 | |
| d. | Weight of residual powder in medium size gloves : 0.50 ± 0.20 mg | |||
| e. | Total water extractable protein 50 microgram/gram (maximum) | |||
| f. | Bio-Compatibility (attached) | Annexure XII | ||
| g. | Test Results as per ASTM D 3578 - 95 (attached) | Annexure V |
- (6) Performance data is the same as mentioned immediately above.
- (7) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (8) Non-clinical data Gloves meet or exceed the ASTM Standard. Meets FAD pin hole requirement. Meets labeling claim.
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K 4782897
MATERIALS USED FOR THE PRODUCTION OF LATEX EXAMINATION GLOVES POWDER - FREE WITH PROTEIN CLAIM
| Dry Weight | |
|---|---|
| 60 % Concentrated Natural Rubber Latex | - 100 |
| KOH Solution | - 0.10 |
| Zinc diethyl dithiocarbamate | - 0.50 |
| Zinc dibutyl dithiocarbamate | - 0.30 |
| Zinc oxide | - 0.75 |
| Sulphur | - 0.80 |
| Titanium dioxide | - 0.60 |
| BHT | - 1.50 |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EE 2 3 1936
P.T. Maja Agung Latexindo C/O Ms. Emmy Tjoenq Official Correspondent Glove Source, Incorporated 345 Cloverleaf Drive, Suite B Baldwin Park, California 91706
Re : K982897 Powder-Free Latex Examination Glove with Trade Name: Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY November 25, 1998 Dated: November 27, 1998 Received:
Dear Ms. Tjoeng:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Ms. Tjoeng
through 542 of 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 findinq 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"(21CFR 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/dsma/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PT. MAJA AGUNG LATI
MANUFACTURING OF LATEX GLOV
Jin. Utama No. 98 PUJi MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
62-61 - 85916 Telp. 62-61 - 8591. Fax. 62-61 - 8591
ANNEXURE II
INDICATION FOR USE
| Applicant | : Mr. Hansen Laurence |
|---|---|
| Device Name | : Latex Patient Examination Gloves Powder Free With Protein |
| Indication for use | : Content Labeling Claim ( 50 micrograms or less ) |
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S. Barrett for Ckn
(Division Sign-Off) Division of Death, infection . Satrol, and General Hospital Devices 510(k) Number .
Prescription Use ( Per 21 CFR 801. 109 ) OR
Over-The-Counter Use
( Optional Format 1-2-96 )
§ 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.