(97 days)
Not Found
No
The 510(k) summary describes a standard medical examination glove and its physical properties and performance against chemotherapy drugs. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, and does not provide any therapeutic benefit or treatment to the patient.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical glove made of nitrile rubber, intended to be worn on the hand or finger. There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description focuses on the physical properties and material of the glove, not on any components or processes used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
- Testing: The testing performed relates to the physical integrity and barrier properties of the glove (tensile strength, watertightness, chemotherapy drug permeation), not to the accuracy or performance of a diagnostic test.
In summary, the device is a medical glove used for protection during patient examination, which falls under a different regulatory classification than in vitro diagnostics.
N/A
Intended Use / Indications for Use
A 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.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Tested for use with Chemotherapy Drugs meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves underqoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
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 (medical purposes)
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 non-clinical test for this powder free nitrile examination glove is summarized as per below:
-
Physical Properties: Evaluated tensile (tension) properties of glove using ASTM D412.
- Before aging: Tensile strength 31.2Mpa (Acceptance Criteria: Min 14.0 MPa), Ultimate elongation 594% (Acceptance Criteria: Min 500%). Status: Pass.
- After aging: Tensile strength 34.7Mpa (Acceptance Criteria: Min 14.0 MPa), Ultimate elongation 553% (Acceptance Criteria: Min 400%). Status: Pass.
-
Dimension: Measured length, width, and thickness of glove using ASTM D3767.
- X-Small: Length 250 mm (Min 240 mm), Width 78.0 mm (70 ± 10 mm), Thickness Finger 0.10 mm (min 0.05mm), Palm 0.07 mm (min 0.05mm). Status: Pass.
- Small: Length 250 mm (Min 240 mm), Width 88.0 mm (80 ± 10 mm), Thickness Finger 0.10 mm (min 0.05mm), Palm 0.07 mm (min 0.05mm). Status: Pass.
- Medium: Length 250 mm (Min 240 mm), Width 98.0 mm (95 ± 10 mm), Thickness Finger 0.10 mm (min 0.05mm), Palm 0.07 mm (min 0.05mm). Status: Pass.
- Large: Length 250 mm (Min 240 mm), Width 108 mm (110 ± 10 mm), Thickness Finger 0.10 mm (min 0.05mm), Palm 0.07 mm (min 0.05mm). Status: Pass.
- X-Large: Length 250 mm (Min 240 mm), Width 118 mm (120 ± 10 mm), Thickness Finger 0.10 mm (min 0.05mm), Palm 0.07 mm (min 0.05mm). Status: Pass.
-
Watertight: Detected holes using ASTM D5151.
- Sample size: 315 pcs (batch size 150,001 to 500,000 for sampling code M).
- Acceptance Criteria: AQL 1.5, Acceptance No. 10.
- Results: 1 piece found with leaks, which falls within the acceptance criteria. Status: Pass.
-
Residual Powder: Determined amount of residual powder using ASTM D6124.
- Sample size: 5 pcs.
- Requirement: 240 minutes breakthrough detection time (Predicate was >240).
- Cyclophosphamide (Cytoxan): >240 minutes breakthrough detection time (Predicate was >240).
- Dacarbazine: >240 minutes breakthrough detection time (Predicate was >240).
- Doxorubicin HCI: >240 minutes breakthrough detection time (Predicate was >240).
- Etoposide: >240 minutes breakthrough detection time (Predicate was >240).
- Fluorouracil: >240 minutes Breakthrough Detection Time (Predicate was >240).
- Ifosfamide: >240 minutes Breakthrough Detection Time (Predicate was >240).
- Methotrexate: >240 minutes Breakthrough Detection Time (Predicate was >240).
- Mitomycin C: >240 minutes Breakthrough Detection Time (Predicate was >240).
- Mitoxantrone: >240 minutes Breakthrough Detection Time (Predicate was >240).
- Paclitaxel: >240 minutes Breakthrough Detection Time (Predicate was >240).
- Thiotepa: 98.8 minutes Breakthrough Detection Time (Predicate was 47.4).
- Vincristine Sulfate: >240 minutes Breakthrough Detection Time (Predicate was >240).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 8, 2022
Rimba Glove SDN BHD % Michael Woude U.S Agent Emergo Global Representation LLC 2500 Bee Cave Road Bldg 1, Suite 300 Austin, Texas 78746
Re: K212898
Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC
Dear Michael Woude:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 16, 2021. Specifically, FDA is updating this SE Letter to address a typo in the sponsor name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Clarance Murray, OHT4: Office of Surgical and Infection Control Devices, 301-796-0870, Clarence.Murray@fda.hhs.gov.
Image /page/0/Picture/8 description: The image shows the text "Sincerely," followed by the name "Liqun Zhao -S". The text is written in a clear, legible font and is likely part of a signature or closing statement. The name is slightly larger than the word "Sincerely,". The image appears to be a cropped portion of a larger document.
For Clarence W. Murray, III, Ph.D Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 16, 2021
Rimba Glove SND BHD % Michael Woude U.S Agent Emergo Global Representation LLC 2500 Bee Cave Road Bldg 1. Suite 300 Austin, Texas 78746
Re: K212898
Trade/Device Name: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 4, 2021 Received: September 10, 2021
Dear Michael Woude:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
2
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Liqun Zhao -S
For Clarance W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K212898
Device Name
BLUE NITRILE POWDER FREE PATIENT EXAMINATION GLOVE, NON STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Indications for Use (Describe)
A 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.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Breakthrough Detection Time in Minutes |
|---|---|
| *Carmustine (BCNU) | 23.0 |
| Cisplatin | > 240 |
| Cyclophosphamide (Cytoxan) | > 240 |
| Dacarbazine | > 240 |
| Doxorubicin HCI | > 240 |
| Etoposide | > 240 |
| Fluorouracil | > 240 |
| Ifosfamide | > 240 |
| Methotrexate | > 240 |
| Mitomycin C | > 240 |
| Mitoxantrone | > 240 |
| Paclitaxel | > 240 |
| *Thiotepa | 98.8 |
| Vincristine Sulfate | > 240 |
*CAUTION: Testing showed an average breakthrough time of 23.0 minutes for Carmustine and an average breakthrough time of 98.9 minutes for Thiotepa.
** WARNING: DO NOT USE WITH CARMUSTINE.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
1.0 Submitter:
| Name: | Zahari Bin Darus |
|---|---|
| Address: | Rimba Glove Sdn Bhd |
| Plot 37, Medan Tasek, Tasek Industrial Estate, 31400 Ipoh, | |
| Perak, Malaysia | |
| Phone No.: | +605-5483688 |
| Fax No.: | +605-5481688 |
Date of Summary Prepared: 20th August 2021 (REVISED DATE: 7th Dec 2021)
Identification of the subject device: 2.0
| Trade Name | : Blue Nitrile Powder Free Patient Examination Glove, Non-
Sterile, Tested for use with Chemotherapy Drugs. |
|-----------------------|----------------------------------------------------------------------------------------------------------------|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : 1 |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA, LZC |
3.0 Predicate Device:
K210944
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue).
Company: Harbour Health LLC.
4.0 Description of The Device:
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Tested for use with Chemotherapy Drugs meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves underqoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
5.0 Indication for use:
A patient examination qlove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device has also been tested for use with Chemotherapy Drugs per ASTM D 6978-5(2019). WARNING: DO NOT USE WITH CARMUSTINE.
6.0 Comparison of the Technological Characteristics of the Device:
The Blue Nitrile Powder Free Patient Examination Glove. Non-Sterile tested for use with chemotherapy drugs are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.
6
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATE | ||||
| BLUE | CURRENT | |||
| BLUE | ||||
| 510(k) Number | - | K210944 | K212898 | |
| Manufacturer(s) | - | Harbour Health LLC, New Jersey |
-
| Rimba Glove Sdn Bhd | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger texture | Finger Texture | Same |
| Physical Properties | ASTM D6319 | | | |
| Before Aging
Tensile Strength:
Ultimate Elongation: | | ≥ 14Mpa
500% | 31.2Mpa
594% | Different but
within the ASTM
standard |
| After Aging
Tensile Strength:
Ultimate Elongation: | | ≥ 14Mpa
400% | 34.7Mpa
553% | Different but
within the ASTM
standard |
| Thickness:
- Finger
- Palm | ASTM D6319 | 0.05mm
0.05mm | 0.10mm
0.07mm | Different but
within the ASTM
standard |
| Powder Free | ASTM D6124 | ≤ 2 mg/glove | 0.26 mg/glove | Different but
within the ASTM
standard |
| | | DEVICE PERFORMANCE | | |
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON
ANALYSIS |
| | | BLUE | BLUE | |
| | Primary Skin Irritation - ISO 10993-10:2010
(E) & Consumer
Product Safety
Commission Title 16.
Chapter II, Part 1500 | Under the condition of study,
the device is a non-irritant | Under the conditions of study,
the test material did not cause
an irritant response. The
Primary Irritant Response
Category is deemed 'Negligible' | Similar |
| | Dermal Sensitization-
ISO 10993-10: 2010
(E) & Consumer
Product Safety
Commission, Title 16,
Chapter II, Part
1500.3 (c) (4) | Under the conditions of the
study, the device is a non-
sensitizer | Under the conditions of study,
the test material did not
produce a skin sensitization
effect in the guinea pigs. | Similar |
| Biocompatibility | Cytotoxicity - MEM
Elution, ISO 10993-5:
2009 (E) | Under the conditions of the
study, the device is potentially
cytotoxic. | Under the conditions of study,
the test material demonstrated
a cytotoxic effect under the
condition of this study.
Additional test i.e. Acute
Systemic Toxicity was tested. | Similar |
| | | DEVICE PERFORMANCE | | |
| CHARACTERISTICS | STANDARDS | PREDICATE | CURRENT | COMPARISON
ANALYSIS |
| | | BLUE | BLUE | |
| Biocompatibility | Acute Systemic
Toxicity,
ISO 10993-
11:2017 (Ε) | Under the conditions of study, the
device does not elicit a systemic
toxicity response in the model
animal. | Under the conditions of study,
the test item did not induce
any systemic toxicity in Swiss
albino mice. | Similar |
| Watertight (1000ml) | ASTM D 6319-
19
ASTM D5151-19 | Complies with ASTM D6319-19 and
ASTM D5151-19, G-1, AQL 2.5 | Gloves passed AQL 1.5 | Different but well
within the ASTM
D6319-19 |
| Intended use | - | The Harbour Health Powder Free
Nitrile Examination Glove, Blue
(Tested for use with Chemotherapy
Drugs) is a disposable device
intended for medical purposes that is
worn on the examiner's hand to
prevent contamination between
patient and examiner. The proposed
device was tested for use with
Chemotherapy drugs per ASTM
D6978-05(2019), Standard Practice
for Assessment of Medical Gloves to
Permeation by Chemotherapy drugs. | A patient examination glove is
a disposable device made of
nitrile rubber intended for
medical purposes that is worn
on the examiner's hand or
finger to prevent contamination
between patient and examiner.
The device has also been
tested for use with
Chemotherapy Drugs per ASTM
D 6978-5(2019) | Same |
| Size | Medical Glove
Guidance
Manual -
Labeling | Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | Similar |
| Single use | Medical Glove
Guidance
Manual -
Labeling | Single Use | Single Use | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Chemotherapy Drugs
Permeation Test | | Minimum Breakthrough
Detection Times in Minutes | Minimum Breakthrough
Detection Times in Minutes | |
| Carmustine (BCNU) -
3.3 mg/ml | | 14.5 | 23.0 | Different in the
result |
| Cisplatin - 1.0 mg/ml | | >240 | >240 | Same |
| Cyclophosphamide (Cytoxan) - 20.0 mg/ml | | >240 | >240 | Same |
| Dacarbazine – 10.0 mg/ml | | >240 | >240 | Same |
| Doxorubicin HCI – 2.0 mg/ml | | >240 | >240 | Same |
| Etoposide - 20.0 mg/ml | | >240 | >240 | Same |
| Fluorouracil – 50.0 mg/ml | ASTM D6879-
5(2019) | >240 | >240 | Same |
| Ifosfamide – 50.0 mg/ml | | >240 | >240 | Same |
| Methotrexate - 25 mg/ml | | >240 | >240 | Same |
| Mitomycin C - 0.5 mg/ml | | >240 | >240 | Same |
| Mitoxantrone – 2 mg/ml | | >240 | >240 | Same |
| Paclitaxel - 6.0 mg/ml | | >240 | >240 | Same |
| Thiotepa – 10 mg/ml | | 47.4 | 98.8 | Different in the
result |
| Vincristine Sulfate - 1 mg/ml | | >240 | >240 | Same |
7
8
9
10
There are no significant differences between the two products and they are the same or similar in terms of intended use, materials design, physical properties, thickness and biocompatibility test.
Summary of Non-Clinical Testing 7.0
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.
11
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Before aging | After aging | Before aging | After aging | |||||
| Physical Properties | ASTM D412 | |||||||
| (Standard Test Method for | ||||||||
| Vulcanized Rubber and Thermoplastic | ||||||||
| Elastomers-Tension) | To evaluate the tensile (tension) properties of glove. | Tensile strength | Min 14.0 MPa | Min 14.0 MPa | 31.2Mpa | 34.7Mpa | Pass | |
| Ultimate elongation | Min 500% | Min 400% | 594% | 553% | Pass |
12
| Test
Method | Standard | Purpose of
Testing | Glove
Size | Acceptance Criteria | | | Results | | | Status |
|----------------|----------------------------------------------------------------------------|--------------------------------------------------------------|---------------|---------------------|-----------------|------------|-----------|---------|----|--------|
| Dimension | ASTM D3767
Standard Practice for
Rubber—Measurement
of Dimensions | To measure the
length, width
and thickness
of glove | X-Small | Length | Min 240 mm | | Length | 250 mm | | Pass |
| | | | | Width | $70 \pm 10$ mm | | Width | 78.0 mm | | Pass |
| | | | | Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass |
| | | | | | Palm | min 0.05mm | | 0.07 mm | | |
| | | | Small | Length | Min 240 mm | | Length | 250 mm | | Pass |
| | | | | Width | $80 \pm 10$ mm | | Width | 88.0 mm | | Pass |
| | | | | Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass |
| | | | | | Palm | min 0.05mm | | 0.07 mm | | |
| | | | Medium | Length | Min 240 mm | | Length | 250 mm | | Pass |
| | | | | Width | $95 \pm 10$ mm | | Width | 98.0 mm | | Pass |
| | | | | Thickness | Finger | min 0.05mm | Thickness | 0.10 | mm | Pass |
| | | | | | Palm | min 0.05mm | | 0.07 mm | | |
| | | | Large | Length | Min 240 mm | | Length | 250 mm | | Pass |
| | | | | Width | $110 \pm 10$ mm | | Width | 108 mm | | Pass |
13
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | ||||
|---|---|---|---|---|---|---|---|---|
| Palm – min 0.05mm | 0.07 mm | |||||||
| X-Large | Length | Min 240 mm | Length | 250 mm | Pass | |||
| Width | $120 \pm 10$ mm | Width | 118 mm | Pass | ||||
| Thickness | Finger – min 0.05mm | Thickness | 0.10 mm | Pass | ||||
| Palm – min 0.05mm | 0.07 mm |
14
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Watertight | ASTM D5151
(Standard Test
Method for
Detection of Holes
in Medical Gloves) | To detect holes
that leak water
and thereby
compromise the
usefulness of the
glove. | Sample size: 315 pcs
Inspection level: G1
AQL: 1.5, Acceptance No. 10 | The batch size for this
sampling is 150,001 to
500,000. Hence,
according to the single
sampling plan GI, the
sample to be drawn is
under code M
equivalent to 315
pieces with accept 10
and reject 11 to be
accepted under AQL
1.5. During the test, 1
piece was found with
leaks. Hence it falls
within the acceptance
criteria. | Pass |
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------|--------|
| Residual
Powder | ASTM D6124
(Standard Test
Method for Residual
Powder on Medical
Gloves) | To determine the
amount of
residual powder
and non-powder
solids found on
gloves. | Less than 2 mg per glove | Sample size : 5 pcs
Requirement :