Search Results
Found 1843 results
510(k) Data Aggregation
(119 days)
California 91764
Re: K253160
Trade/Device Name: Syntex Exam Gloves
Regulation Number: 21 CFR 880.6250
Powder-Free Exam Gloves
Classification Name: Non-Powdered Patient Examination Glove
Regulation: 21 CFR 880.6250
Synguard Nitrile Exam Glove | - |
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250
| 21 CFR 880.6250 | Same |
| Device Classification | Class I | Class I | Same |
| Indications for use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Syntex Exam Gloves is a Class I patient examination glove, that made from synthetic Butadiene-acrylonitrile latex. They are natural latex color, non-sterile, powder-free, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.
The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility.
N/A
Ask a specific question about this device
(173 days)
Device Name:** Cardinal Health Nitrile Examination Gloves Extended Cuff
Regulation Number: 21 CFR 880.6250
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 examiner. The gloves was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs".
The following drugs have been tested with these gloves:
| Chemotherapy Drug & Concentration | Minimum Breakthrough Detection Time in Minutes, 0.01 μg/cm2/min: |
|---|---|
| Bendamustine HCl, 5 mg/ml (5,000 ppm) | >240 min |
| Bleomycin Sulfate, 15 mg/ml (15,000 ppm) | >240 min |
| Busulfan, 6 mg/ml (6,000 ppm) | >240 min |
| Carboplatin, 10 mg/ml (10,000 ppm) | >240 min |
| Carmustine 3.3 mg/ml (3,300 ppm) | 10.0 min |
| Chloroquine, 50 mg/ml (50,000 ppm) | >240 min |
| Cisplatin, 1mg/ml (1000 ppm) | >240 min |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 min |
| Cytarabine HCl (Cytosine), 100 mg/ml (100,000 ppm) | >240 min |
| Dacarbazine (DTIC), 10 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 min |
| Epirubicin HCl, 2 mg/ml (2,000 ppm) | >240 min |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 min |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 min |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 min |
| Gemcitabine HCl, 38 mg/ml (38,000 ppm) | >240 min |
| Idarubicin HCl, 1 mg/ml (1,000 ppm) | >240 min |
| Ifosfamide (IFEX), 50 mg/ml (50,000 ppm) | 80.0 min |
| Mechlorethamine HCl, 1 mg/ml (1,000 ppm) | >240 min |
| Melphalan HCl, 5 mg/ml (5,000 ppm) | >240 min |
| Methotrexate, 25mg/ml (25,000ppm) | >240 min |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 min |
| Mitoxantrone HCl (2.0 mg/mL) (2000 ppm) | >240 min |
| Oxaliplatin, 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 min |
| Rituximab, 10 mg/ml (10,000 ppm) | >240 min |
| Thiotepa, l0mg/ml (10,000ppm) | 20.0 min |
| Trisenox (Arsenic Trioxide), 1 mg/ml (1,000 ppm) | >240 min |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 min |
| Vinorelbine, 10 mg/ml (10,00 ppm) | >240 min |
| Opioid Drug | Minimum Breakthrough Detection Time in Minutes, 0.01 μg/cm2/min: |
|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 min |
*Please note that the following drugs have low permeation times:
Carmustine: 10.0 minutes, Thiotepa: 20.0 minutes
Warning: Do not use with Carmustine & Thiotepa.
Caution: Testing showed breakthrough time of 80.0 minutes with Ifosfamide IFEX (50.0 mg/mL).
Not Found
N/A
Ask a specific question about this device
(153 days)
Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
Regulation Number: 21 CFR 880.6250
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid as per ASTM D6978-05 (Reapproved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drugs Permeation Test:
- Carmustine (BCNU) (3.3 mg/ml): White-Green (30.0 minutes), White-Blue (30.0 minutes)
- Cisplatin (1.0 mg/ml): White-Green (>240), White-Blue (>240)
- Cyclophosphamide (Cytoxan) (20.0 mg/ml): White-Green (>240), White-Blue (>240)
- Cytarabine HCl (100 mg/ml): White-Green (>240), White-Blue (>240)
- Dacarbazine (DTIC) (10.0 mg/ml): White-Green (>240), White-Blue (>240)
- Doxorubicin Hydrochloride (2.0 mg/ml): White-Green (>240), White-Blue (>240)
- Etoposide (20.0 mg/ml): White-Green (>240), White-Blue (>240)
- Fluorouracil (50.0 mg/ml): White-Green (>240), White-Blue (>240)
- Ifosfamide (50.0 mg/ml): White-Green (>240), White-Blue (>240)
- Methotrexate (25.0 mg/ml): White-Green (>240), White-Blue (>240)
- Mitomycin C (0.5 mg/ml): White-Green (>240), White-Blue (>240)
- Mitoxantrone (2.0 mg/ml): White-Green (>240), White-Blue (>240)
- Paclitaxel (Taxol) (6.0 mg/ml): White-Green (>240), White-Blue (>240)
- Thiotepa (10.0 mg/ml): White-Green (60.0 minutes), White-Blue (80.0 minutes)
- Vincristine Sulfate (1.0 mg/ml): White-Green (>240), White-Blue (>240)
Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 30.0 and 60.0 minutes respectively (for White-Green), and 30.0 and 80.0 minutes respectively (for White-Blue).
Warning: Do not use with Carmustine and Thiotepa
Opioid Drugs and Others Permeation Test:
- Fentanyl Citrate Injection (100mcg/2mL): White-Green (>240), White-Blue (>240)
- Simulated Gastric Acid: White-Green (>240), White-Blue (>240)
- Xylazine HCl (100 mg/ml): White-Green (>240), White-Blue (>240)
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
N/A
Ask a specific question about this device
(217 days)
Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Regulation Number: 21 CFR 880.6250
Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Regulation Number: 21 CFR 880.6250
Powder-Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
Warning - Not for Use with Carmustine and Thiotepa
Powder-Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
Warning - Not for Use with Carmustine and Thiotepa
Not Found
N/A
Ask a specific question about this device
(82 days)
Disposable Vinyl Examination Gloves 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.
Not Found
N/A
Ask a specific question about this device
(216 days)
Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
Regulation Number: 21 CFR 880.6250
Black)
Device Class: 1
Product Code: LZA, LZC, QDO, OPJ
Regulation Number: 21 CFR 880.6250
LZA, LZC, QDO | LZA, LZC, QDO | Same |
| Classification | 1 | 1 | Same |
| Regulation Number | 21 CFR 880.6250
| 21 CFR 880.6250 | Same |
| Regulation Name | Non-Powder Patient Examination Glove | Non-Powder Patient
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid. The gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|---|
| Azacytidine | (25.0 mg/ml) | >240 |
| Carmustine | (3.3 mg/ml) | 25.0 |
| Cisplatin | (1.0 mg/ml) | >240 |
| Cyclophosphamide | (20.0 mg/ml) | >240 |
| Carboplatin | (10.0 mg/ml) | >240 |
| Dacarbazine | (10.0 mg/ml) | >240 |
| Docetaxel | (10.0 mg/ml) | >240 |
| Doxorubicin HCl | (2.0 mg/ml) | >240 |
| Epirubicin | (2.0 mg/ml) | >240 |
| Etoposide | (20.0 mg/ml) | >240 |
| Fluorouracil | (50.0 mg/ml) | >240 |
| Gemcitabine | (38.0 mg/ml) | >240 |
| Ifosfamide | (50 mg/ml) | >240 |
| Irinotecan | (20.0 mg/ml) | >240 |
| Methotrexate | (25.0 mg/ml) | >240 |
| Mitomycin C | (0.5 mg/ml) | >240 |
| Mitoxantrone | (2.0 mg/ml) | >240 |
| Oncovin | (1.0mg/ml) | >240 |
| Oxaliplatin | (5.0 mg/ml) | >240 |
| Paclitaxel | (6.0 mg/ml) | >240 |
| Thiotepa | (10.0 mg/ml) | 55.7 |
| Vinorelbine | (10.0 mg/ml) | >240 |
| Vincristine Sulfate | (1.0 mg/ml) | >240 |
Testing showed a minimum breakthrough time of 25.0 minutes with Carmustine and 55.7 minutes with Thiotepa
Warning: Do not use with Carmustine
| Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100 mcg/2ml | >240 |
| Fentanyl Citrate mixed with Simulated Gastric Acid at a 50:50 ratio | >240 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) is a disposable single-use, non-sterile, Black and powder-free ambidextrous glove made from nitrile butadiene rubber.
N/A
Ask a specific question about this device
(107 days)
Device Name: Program insite® Powder-Free, Disposable Nitrile Exam Gloves
Regulation Number: 21 CFR 880.6250
General Hospital |
| Regulatory Class: | Class I (Reserved) |
| Regulation Number: | 21 CFR 880.6250
Powder‑Free Nitrile | Similar |
| Device Description / Regulation | Patient examination glove / 21 CFR 880.6250
| Patient examination glove / 21 CFR 880.6250 | Same |
| Product Code | LZA | LZA | Same |
| **Indications
Nitrile Glove (K190159) have the same intended use (patient examination glove), regulation (21 CFR 880.6250
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.
The powder-free nitrile exam gloves are non-sterile, single-use, ambidextrous medical examination gloves made from nitrile butadiene rubber (NBR). They are blue, feature a beaded cuff, and are available in sizes S–XL. The gloves are not made with natural rubber latex.
Their physical and performance characteristics meet all requirements of ASTM D6319-19. The gloves are powder-free and meet the requirements of ASTM D6124-06. Powder is not used during any stage of manufacturing. Rather, the gloves are manufactured using a non-chlorinated polyurethane (PU) inner coating to reduce surface friction and facilitate donning. More specifically, following the dipping phase, the gloves pass through gelling and pre-curing ovens to stabilize the film and control thickness and tactile responsiveness. The PU coating is applied to the inner (donning) surface and then dried and cured, producing a smooth, low-friction finish. Residual processing aids are removed through rinsing/drying steps, resulting in a stable, non-reactive donning surface. Automated cuff beading is then performed to enhance edge durability and ease of application.
N/A
Ask a specific question about this device
(20 days)
K252505**
Trade/Device Name: Powder-Free Vinyl Exam Gloves, clear
Regulation Number: 21 CFR 880.6250
Name:** Non-Powdered Patient Examination Glove
Model(s): S, M, L, XL
Regulation: 21 CFR 880.6250
Disposable Vinyl Examination Glove | - |
| Product Code | LYZ | LYZ | Same |
| Regulation Number | 21 CFR 880.6250
| 21 CFR 880.6250 | Same |
| Indications for use | Powder-Free Vinyl Exam Gloves, clear is a disposable
Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device is a powder free vinyl patient examination glove, provided as non-sterile and disposable device. It is provided with clear color. Available in four sizes small, medium, large, and extra - large users can choose the most suitable option.
The provided FDA 510(k) clearance letter and summary describe the regulatory approval process for "Powder-Free Vinyl Exam Gloves, clear." This is a Class I medical device, and the clearance is based on demonstrating substantial equivalence to a predicate device, K220469, "Disposable Vinyl Examination Glove."
The study described is not a clinical study involving human patients or complex AI algorithms necessitating multi-reader, multi-case (MRMC) studies or expert adjudication of medical images. Instead, it's a non-clinical performance study focused on the physical, chemical, and biological properties of the gloves.
Therefore, many of the requested points related to AI performance, human reader improvement, and complex ground truth establishment for medical diagnosis are not applicable to this type of device and study.
Here's the breakdown of the information that is applicable:
Acceptance Criteria and Device Performance for Powder-Free Vinyl Exam Gloves, Clear
The acceptance criteria and device performance are primarily based on non-clinical testing according to recognized industry standards (ASTM and ISO). The goal is to demonstrate that the subject device meets the same performance specifications as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology (Standard) | Test Performed | Acceptance Criteria | Reported Device Performance | Outcome |
|---|---|---|---|---|
| ASTM D5250-19, ASTM D3767-03 | Physical Dimensions: Length | S/M/L/XL: 230 mm | 230 mm | Pass |
| Physical Dimensions: Width | S: 85±5 mm; M: 95±5 mm; L: 105±5 mm; XL: 115±5 mm | S: 85-86 mm; M: 95-96 mm; L: 104-106 mm; XL: 115-116 mm | Pass | |
| Physical Dimensions: Thickness | Finger: 0.08 mm; Palm: 0.08 mm | Finger: 0.09-0.12 mm; Palm: 0.08-0.10 mm | Pass | |
| ASTM D5250-19, ASTM D412-16 | Physical Properties: Before aging (Tensile strength) | 11 MPa, min | 14 - 22 MPa | Pass |
| Physical Properties: Before aging (Ultimate elongation) | 300%, min | 302 - 419 % | Pass | |
| Physical Properties: After aging (Tensile strength) | 11 MPa, min | 14 - 21 MPa | Pass | |
| Physical Properties: After aging (Ultimate elongation) | 300%, min | 303 - 433 % | Pass | |
| ASTM D5250-19, ASTM D5151-19 | Water leak test (Freedom from holes) | G-I, AQL 2.5 (ISO 2859-1) | Pass | Pass |
| ASTM D5250-19, ASTM D6124-06 | Powder Residue | Max 2 mg/glove | 0.37-0.53 mg | Pass |
| ISO 10993-10:2021 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. | Pass |
| ISO 10993-23:2021 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. | Pass |
| ISO 10993-5:2009 | Cytotoxicity | Non-Cytotoxicity | Under conditions of the study, device is not cytotoxic. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a precise numerical sample size (e.g., number of gloves) for each non-clinical test. However, it indicates that testing was performed according to the specified ASTM and ISO standards, which inherently define the necessary sample sizes and methodologies for ensuring statistical validity within their respective contexts (e.g., AQL for the water leak test).
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the "Basic Medical Technology Inc." is located in Ontario, CA (presumably California, USA) and the predicate device manufacturer is a Chinese company (CHIFENG HUAWEI MEDICAL SCIENCE TECHNOLOGY CO., LTD.), the testing could have been performed either in the US, China, or accredited labs elsewhere.
- Retrospective or Prospective: This testing is inherently prospective as it involves the manufacturing and testing of new device samples to demonstrate compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: For this type of non-clinical device (medical gloves), "ground truth" is not established by medical experts interpreting images or clinical data. Instead, it's established by the physical and chemical properties of the material as measured by standardized laboratory methods. The "experts" would be the accredited laboratory personnel performing the tests according to the ASTM and ISO standards, not medical professionals like radiologists.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations of complex data (like medical images). This is a physical product testing scenario where results are quantitative measurements against objective criteria, so no adjudication by multiple human observers is required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in tasks like diagnostic imaging. This device is a pair of medical gloves; there is no AI component or human reader interpretation task involved.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not Applicable: This pertains to AI algorithm performance evaluation. There is no AI algorithm in "Powder-Free Vinyl Exam Gloves, clear." The "standalone" performance here refers to the device's physical and biological properties.
7. Type of Ground Truth Used
- The "ground truth" for this device is based on objective, standardized measurements of its physical properties (e.g., dimensions, tensile strength, elongation, hole detection) and biological compatibility (e.g., cytotoxicity, irritation, sensitization), as defined by internationally recognized ASTM and ISO standards. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
- Not Applicable: This is not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm. The manufacturing process of the gloves would have its own quality control and process validation, which might involve data collection analogous to a training set for process refinement, but this is distinct from AI model training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no AI training set, this question is irrelevant.
Ask a specific question about this device
(84 days)
Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
Regulation Number: 21 CFR 880.6250
Exam Gloves
Classification Name: Non-Powdered Patient Examination Glove
Regulation: 21 CFR 880.6250
LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Regulation Number | 21 CFR 880.6250
| 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Device Classification | Class I | Class I | Class I |
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are pink color, non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.
The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been been tested for biocompatibility and permeability to chemotherapy drugs, Fentanyl Citrate, Gastric Acid and Xylazine in Fentanyl Citrate.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device submitted for FDA 510(k) clearance.
The device in question is Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate.
Acceptance Criteria and Device Performance Study
The acceptance criteria for this device are primarily based on established industry standards for medical examination gloves and specific permeation resistance tests for various chemical substances. The study conducted to prove the device meets these criteria is a series of non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Meet requirement inspection level G-1, AQL 2.5 (ISO2859-1) | Pass |
| Dimension - Length | ASTM D6319-19 | Minimum 220mm for size XS-S Minimum 230mm for size M-XXL | Pass |
| Dimension - Width | ASTM D6319-19 | XS: 70±10mm S: 80±10mm M: 95±10mm L: 110±10mm XL: 120±10mm XXL: 130±10mm | Pass |
| Dimension - Thickness | ASTM D6319-19 | Finger: 0.05mm (min) Palm: 0.05mm (min) | Pass |
| Physical Properties | ASTM D6319-19, ASTM D412-16 | Before aging: Tensile Strength (Min 14 Mpa) Elongation (Min 500%) After aging: Tensile Strength (Min 14 Mpa) Elongation (Min 400%) | Pass (All criteria met) |
| Powder Residue | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Pass |
| Skin Irritation (Biocompatibility) | ISO10993-23:2021 | Under the conditions of the study, not a primary skin irritant | Pass (Not a primary skin irritant) |
| Skin Sensitization (Biocompatibility) | ISO10993-10:2021 | Under the conditions of the study, not a contact sensitizer | Pass (Not a contact sensitizer) |
| Acute Systemic Toxicity (Biocompatibility) | ISO 10993-11:2017 | Under the conditions of the study, no signs of acute systemic toxicity were observed | Pass (No signs of acute systemic toxicity were observed) |
| Chemotherapy Drugs Permeation | ASTM D6978-05 (2023) | Minimum Breakthrough Detection Time (minutes) Carboplatin: >240 Carmustine: Varies (15.3 min reported) Cisplatin: >240 Cyclophosphamide: >240 Cytarabine HCl: >240 Dacarbazine: >240 Daunorubicin HCl: >240 Doxorubicin HCl: >240 Etoposide: >240 5-Fluorouracil: >240 Gemcitabine HCl: >240 Ifosfamide: >240 Irinotecan HCl: >240 Mechlorethamine HCl: >240 Melphalan HCl: >240 Methotrexate: >240 Mitomycin-C: >240 Mitoxantrone HCl: >240 Pacilitaxel: >240 Thiotepa: Varies (28.2 min reported) | Carboplatin: >240 min. Carmustine: 15.3 min. Cisplatin: >240 min. Cyclophosphamide: >240 min. Cytarabine HCl: >240 min. Dacarbazine: >240 min. Daunorubicin HCl: >240 min. Doxorubicin HCl: >240 min. Etoposide: >240 min. 5-Fluorouracil: >240 min. Gemcitabine HCl: >240 min. Ifosfamide: >240 min. Irinotecan HCl: >240 min. Mechlorethamine HCl: >240 min. Melphalan HCl: >240 min. Methotrexate: >240 min. Mitomycin-C: >240 min. Mitoxantrone HCl: >240 min. Pacilitaxel: >240 min. Thiotepa: 28.2 min. Note: The document explicitly states that Carmustine and Thiotepa have "extremely low permeation times" and are accompanied by a "Warning: Do not use with Carmustine and Thiotepa," indicating that the stated permeation times for these two drugs are not >240 minutes and are accepted for the specified usage. |
| Fentanyl, Gastric Acid, Xylazine Permeation | ASTM D6978-05 (2023) | Minimum Breakthrough Detection Time (minutes) Fentanyl Citrate Injection: >240 Simulated Gastric Acid: >240 Fentanyl Citrate:Xylazine HCl (50:50): >240 | Fentanyl Citrate Injection: >240 min. Simulated Gastric Acid: >240 min. Fentanyl Citrate (50mcg/ml): Xylazine HCl (100mg/ml), 50:50: >240 min. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of gloves) used for each individual test. However, it indicates that the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such tests to ensure statistical validity.
The data provenance is through non-clinical testing performed in accordance with recognized international and national standards (ASTM, ISO). This implies the data were prospectively generated for the purpose of this submission. The country of origin of the data is not specified, but the use of international standards suggests a globally accepted testing methodology.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) as the device is a physical product (medical glove) and the performance is evaluated through objective, standardized laboratory tests (e.g., measuring permeation time, tensile strength, dimensions) rather than expert interpretation of images or clinical data. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as above. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. The tests performed for this device are objective measurements.
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
This information is not applicable (N/A). This document pertains to the clearance of a physical medical device (gloves), not an AI algorithm or a diagnostic imaging device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable (N/A). As mentioned, this is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective, quantitative measurements obtained through standardized laboratory testing methodologies (ASTM and ISO standards). For example:
- Permeation: Measured breakthrough time of specific chemicals through the glove material.
- Physical Properties: Measured tensile strength, elongation, length, width, and thickness.
- Biocompatibility: Observed biological responses (e.g., irritation, sensitization, systemic toxicity) in controlled in-vitro or in-vivo (animal) tests as per ISO standards.
This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on direct physical and chemical testing.
8. The Sample Size for the Training Set
This information is not applicable (N/A). This device is a manufactured product that undergoes performance and biocompatibility testing. There is no "training set" in the context of machine learning. The manufacturing process is designed and validated to consistently produce gloves meeting the specified criteria.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) as there is no training set for this device. The "ground truth" for the device's design and manufacturing is derived from the established standards (ASTM, ISO) that define the performance characteristics expected of such gloves. Quality control during manufacturing ensures conformity to these standards.
Ask a specific question about this device
(34 days)
Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
Regulation Number: 21 CFR 880.6250
Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250
Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250
| 21 CFR 880.6250 | same |
| Class | I | I | same |
| Indications for Use | The nitrile powder free
| 21 CFR 880.6250 | same |
| Class | I | I | same |
| Indications for Use | The nitrile powder free
Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
Warning: do not use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
- Carmustine (BCNU) 3.3 mg/ml 21.5 minutes
- Thiotepa 10.0 mg/ml 13.6 minutes
"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
The provided document is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid."
This is a physical medical device (a glove), not a software device or an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML model validation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of FDA submission.
The document assesses the device's physical properties and its resistance to permeation by various hazardous substances. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to bench testing against established ASTM and CFR standards for medical gloves.
Here's the breakdown of the relevant information from the document, tailored to the nature of this device:
Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
The device (Disposable Powder Free Nitrile Examination Glove, Blue Color) was tested against several physical and chemical permeation standards. The acceptance criteria and results are outlined in the "Assessment of Non-Clinical Performance Data" section (Page 17-19) and the "Indications for Use" section (Page 4-5) and summarized within the "510(k) Summary" (Page 7-11).
| Test | Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D6319-19 | Determine the geometrical dimension of gloves | Length: Short cuff: ≥230mm; Long cuff: ≥300mmThickness: Palm: ≥ 0.05 mm; Finger: ≥ 0.05 mm; Cuff: ≥ 0.05 mmPalm Width: XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm | Pass |
| Freedom from holes (Water leak) | 21 CFR 800.20. & ASTM D5151-19 | Detect the holes on the gloves. | G-I/ AQL 2.5 | Pass |
| Tensile strength (Before aging/ After aging) | ASTM D6319-19 | Evaluate the tensile (tension) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves. | Before Aging: ≥14MPaAfter Aging: ≥14MPa | Pass |
| Elongation (Before aging/ After aging) | ASTM D6319-19 | Related to tensile properties, measures stretchiness. | Before Aging: ≥500%After Aging: ≥400% | Pass |
| Powder Residual | ASTM D6319-19 | Determine the average powder mass found on the gloves | ＜ 2mg per glove | Pass |
| Biocompatibility - Cytotoxicity | AAMI/ANSI/ISO 10993-5 | Determine the cytotoxicity potential of glove | No in vitro cytotoxic as described in ISO 10993-5 | Pass |
| Biocompatibility - Skin Sensitization and Irritation | AAMI/ANSI/ISO 10993-10 | Determine the potential of glove to promote skin sensitization after repeated applications.Determine the potential of gloves to promote skin irritation after repeated applications. | No dermal reactions indicative of delayed contact hypersensitivityNo skin irritation, cumulative irritation index to be 0. | Pass |
| Resistance of Gloves to Permeation by Chemotherapy and Other Liquid Hazardous Drugs, and Non-drugs Solution | ASTM D6978-05 | Assessment of medical gloves to permeation by chemotherapy and other liquid hazardous drugs, and non-drugs solution. | The resistance of the device to permeation were challenged against 59 hazardous drugs and 1 non-drugs simulated solution. General Acceptance Standard (Implicit): Maintain barrier protection for a minimum period. The tables on pages 4-5 and 7-11 list Minimum Breakthrough Detection Time (Min.) for each substance. For most substances, the acceptance criterion was ">240 minutes", meaning no breakthrough occurred within the 240-minute test period. For Carmustine and Thiotepa, specific breakthrough times (21.5 and 13.6 minutes, respectively) were observed and noted as limitations/warnings. | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state numerical sample sizes for each specific test (e.g., how many gloves were tested for a burst, tensile, or permeation). However, it implies that testing was conducted according to the specified ASTM and FDA methodologies, which inherently define minimum sample sizes for material testing (e.g., AQL levels for freedom from holes).
- Data Provenance: The tests are "bench testing" conducted on physical glove samples. The manufacturer is "Ever Global (Vietnam) Enterprise Corporation" from Vietnam, so the testing was likely conducted in accordance with international standards at a facility associated with the manufacturer or a certified testing lab. The data is non-clinical performance data from laboratory experiments, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is a physical device subject to material property and permeation testing, "ground truth" is established by adherence to physical measurement standards and chemical analysis protocols (e.g., ASTM D6319-19 for physical properties, ASTM D6978-05 for permeation). No human expert interpretation or consensus is required to establish the "truth" of a chemical breakthrough time or tensile strength value.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant in subjective human interpretation tasks (e.g., radiology image reading). For objective bench testing of physical properties, results are determined by instrumentation and adherence to standardized protocols, not human 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. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in medical imaging. This is a physical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is established through objective, standardized laboratory measurement methods as defined by the referenced ASTM (American Society for Testing and Materials) and CFR (Code of Federal Regulations) standards.
- For physical properties (Dimensions, Tensile Strength, Elongation, Powder Residual, Freedom from Holes), the ground truth is the measured physical values against the defined thresholds in ASTM D6319-19 and 21 CFR 800.20 & ASTM D5151-19.
- For chemical permeation (Resistance to Hazardous Drugs), the ground truth is the measured breakthrough time determined by chemical analysis according to ASTM D6978-05.
- For Biocompatibility, the ground truth is the biological response (cytotoxicity, dermal reactions) as measured per AAMI/ANSI/ISO 10993-5 and 10993-10 standards.
8. The sample size for the training set:
- Not Applicable. This is a physical product, not a machine learning model; therefore, there is no "training set." The product's design and manufacturing process are developed through engineering and material science, not data training.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for this physical device.
Ask a specific question about this device
Page 1 of 185